FDA Registration Active 🇨🇭 Switzerland

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Reg #: 3003795116 · FEI: 3003795116 · Expires 2026
Products
158
Proprietary Names
875
Establishment Types
5
Classifications
158

Registration Details

Registration Name
ROCHE DIAGNOSTICS INTERNATIONAL LTD.
Registration Number
3003795116
FEI Number
3003795116
Status
Active
Expiry Year
2026
Initial Importer
No
Address
FORRENSTRASSE 2
City
ROTKREUZ Zug
Country
CH

Regulatory Submissions

510(k) Number
K220134
PMA Number
P200014

Owner / Operator

Firm Name
Roche Diagnostics Operations Inc.
Operator Number
9039767
Address
9115 Hague Road
City
Indianapolis
State
IN
Postal Code
46250
Country
US

US Agent

Business Name
Roche Diagnostics Operations Inc
Contact Name
Brian Frazier
Address
9115 Hague Rd
City
Indianapolis
State
IN
ZIP
46256
Country
US
Phone
317 5214603

Products

Device Name Product Code
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Radioimmunoassay, Thyroid-Stimulating Hormone JLW
Enzyme Immunoassay, Methadone DJR
Electrode, Ion Specific, Sodium JGS
Hexokinase, Glucose CFR
Multi-Analyte Controls, All Kinds (Assayed) JJY
Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
Real Time Nucleic Acid Amplification System OOI
Dna-Reagents, Neisseria LSL
Somatic Gene Mutation Detection System OWD
Fluorescence Polarization Immunoassay, Theophylline LGS
Iga, Antigen, Antiserum, Control CZP
Lipoprotein X, Antigen, Antiserum, Control DEL
Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
Bromcresol Green Dye-Binding, Albumin CIX
Fluorescence Polarization Immunoassay, Carbamazepine LGI
Enzyme Immunoassay, Amphetamine DKZ
Enzymatic Esterase--Oxidase, Cholesterol CHH
Enzyme Immunoassay, Cocaine JXO
Diazo Colorimetry, Bilirubin CIG
Enzyme Immunoassay, Opiates DJG
Photometric Method, Iron (Non-Heme) JIY
Enzyme Immunoassay, Cannabinoids LDJ
Transferrin, Antigen, Antiserum, Control DDG
Enzyme Immunoassay, Benzodiazepine JXM
Complement C4, Antigen, Antiserum, Control DBI
Turbidimetric Method, Lipoproteins JHN
Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
Olive Oil Emulsion (Turbidimetric), Lipase CET
Calibrators, Drug Mixture DKB
Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
Enzyme Immunoassay, Phencyclidine LCM
Assay, Glycosylated Hemoglobin LCP
System, Test, C-Reactive Protein DCN
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) MOJ
Drug Mixture Control Materials DIF
Enzyme Immunoassay, Phenobarbital DLZ
Calibrators, Drug Specific DLJ
Fluorescence Polarization Immunoassay, Phenobarbital LGQ
Colorimetry, Cholinesterase DIH
Catalytic Methods, Amylase JFJ
Electrode, Ion-Specific, Chloride CGZ
Calibrator, Multi-Analyte Mixture JIX
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
Radioassay, Triiodothyronine Uptake KHQ
Cresolphthalein Complexone, Calcium CIC
Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
Nephelometer JZW
Differential Rate Kinetic Method, Cpk Or Isoenzymes JHS
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
Enzyme Immunoassay, Quinidine LBZ
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
Enzyme Immunoassay, Valproic Acid LEG
System, Test, Urinary Methylmalonic Acid LPT
Biuret (Colorimetric), Total Protein CEK
Complement C3, Antigen, Antiserum, Control CZW
Igg, Antigen, Antiserum, Control DEW
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
Alkaline Picrate, Colorimetry, Creatinine CGX
Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
Enzyme Immunoassay, Digoxin KXT
Photometric Method, Magnesium JGJ
Drug Specific Control Materials LAS
Enzyme Immunoassay, Procainamide LAR
Enzyme Immunoassay, N-Acetylprocainamide LAN
Method, Nephelometric, Immunoglobulins (G, A, M) CFN
Enzyme Immunoassay, Barbiturate DIS
Test, Hiv Detection MZF
Analyzer, Chemistry, Micro, For Clinical Use JJF
Flame Photometry, Lithium JIH
Electrode, Ion Specific, Potassium CEM
Electrode, Ion Specific, Calcium JFP
Hepatitis Viral B Dna Detection MKT
C. Difficile Toxin Gene Amplification Assay OZN
Reagent, Coronavirus Serological QKO
Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
Herpes Simplex Virus Nucleic Acid Amplification Assay OQO
Data Acquisition Software PQQ
Instrumentation For Clinical Multiplex Test Systems NSU
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna QMI
Calculator/Data Processing Module, For Clinical Use JQP
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus MZP
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
Test, Equipment, Automated Bloodborne Pathogen MZA
Respiratory Virus Panel Nucleic Acid Assay System OCC
Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
Oxyhemoglobin GGZ
Whole Blood Hemoglobin Determination KHG
Acid, Lactic, Enzymatic Method KHP
Oximeter To Measure Hemoglobin GLY
Assay, Carboxyhemoglobin GHS
Abnormal Hemoglobin Quantitation GKA
Glucose Oxidase, Glucose CGA
Instrument, Hematocrit, Automated GKF
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
Cytomegalovirus (Cmv) Dna Quantitative Assay PAB
Station, Pipetting And Diluting, For Clinical Use JQW
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
Test, Urine Leukocyte LJX
Automated Urinalysis System KQO
Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
Blood, Occult, Colorimetric, In Urine JIO
Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
Refractometer For Clinical Use JRE
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen NQX
Agent, Clearing KEM
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Kit, Dna Detection, Human Papillomavirus MAQ
Electrode, Ion Specific, Urea Nitrogen CDS
Acid Hematin GGF
System, Hemoglobin, Automated GKR
General Purpose Reagent PPM
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna QLX
Clinical Sample Concentrator JJH
Enzymatic Method, Ammonia JIF
Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
System, Test, Beta-2-Microglobulin Immunological JZG
Acid Phosphatase, Disodium Phenylphosphate CJX
Acid, Uric, Uricase (Colorimetric) KNK
Radioimmunoassay, Methaqualone KXS
Haptoglobin, Antigen, Antiserum, Control DAD
Albumin, Antigen, Antiserum, Control DCF
Colorimetry, Salicylate DKJ
Igm (Mu Chain Specific), Antigen, Antiserum, Control DAO
Colorimetry, Acetaminophen LDP
Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
Immunochemical, Ceruloplasmin CHN
Enzymatic, Carbon-Dioxide KHS
Assay, Porphyrin, Spectrophotometry, Lithium NDW
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
Radioimmunoassay, Tobramycin KLB
Test, Cystatin C NDY
System, Test, Rheumatoid Factor DHR
Fibrin Split Products GHH
Radioimmunoassay, Lsd (125-I) DLB
Ferritin, Antigen, Antiserum, Control DBF
Mycophenolic Acid Test System OAV
Turbidimetric, Total Protein JGQ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
Radioimmunoassay, Vancomycin LEH
Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
Amikacin Serum Assay KLP
Enzyme Immunoassay, Diphenylhydantoin DIP
Alpha-1-Lipoprotein, Antigen, Antiserum, Control DER
System, Test, Low Density, Lipoprotein MRR
Ferrozine (Colorimetric) Iron Binding Capacity JMO
Bromcresol Purple Dye-Binding, Albumin CJW
Enzyme Immunoassay, Propoxyphene JXN
Enzyme Immunoassay, Theophylline KLS
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
Myoglobin, Antigen, Antiserum, Control DDR
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method DML

Proprietary Names

cobas pure integrated solutions cobas b 221 SOL CTRL COOX/MSS VERIF 7x4 cobas z 480 Analyzer KIT COBAS PCR MEDIA UNI SWB 100 PKT IVD cobas CT/NG Test, v2 SW c4800 CT/NG AP V. 2.1 CD KIT COBAS 4800 EZH2 AMP/DET 24T IVD cobas® EZH2 Analysis Package Software version 1 cobas® EZH2 Mutation Test SW C4800 EZH2 AP V1 CD COBAS INTEGRA ANALYZER PRODUCTS COBAS INTEGRA SYSTEM TP Gen.2, 300Tests, cobas c, Integra cobas INTEGRA IRON 2 cobas INTEGRA CANNABINOIDS GEN II cobas TDM T4 CALIBRATOR KIT cobas INTEGRA T-UPTAKE 200 cobas c 70X Iron/750 cobas INTEGRA ALANINE TRANSAMINASE 500 AST 1100Tests cobas c 701 Iron Gen2. 100T c111 THEO, 225Tests, cobas Integra PHNO, 200Tests, cobas Integra PHNY, 200Tests, cobas Integra cobas Integra 400 Plus FRUC, 250Tests, cobas c 701 CARB, 200Tests, cobas Integra cobas INTEGRA BENZODIAZEPINES 200 CK-MB 100T c111 Ethanol Gen.2 cobas C INTEGRA FRUC ETOH2, 850T, cobas c 503 cobas INTEGRA 400 Plus cobas c 70X Total Protein/700 cobas THEOPHYLLINE/100 cobas INTEGRA ETOH GEN II cobas INTEGRA ASPARTATE TRANSAMINASE 500 Fructosamine I PHENCYCLIDINE 200 PHOS Gen.2, 250Tests, cobas c, Integra cobas c 70X Phosphorus/600 CREAJ Gen.2, 1500Test, cobas c701 I BARBITURATES 200 cobas C ASTL/PYP Phospor 100T cobas c 111 FRA, 550T, cobas c 503 ETOH2, 150T, cobas c 503 CREAJ Gen.2, 2500Test, cobas c503 Creatinine Jaffe Gen.2 ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES Sample Supply Module V2 cobas 8800 v2 cobas 6800 v2 cobas 6800 2nd Analytical Unit cobas HIV-1 Specimen preparation reagents (cobas omni reagents) cobas HBV/HCV/HIV-1 Control Kit cobas 6800/8800 Systems cobas NHP Negative Control Kit cobas HIV-1 analysis specific analysis package (ASAP) software KIT COBAS 58/68/8800 HIV 192T IVD cobas® HIV-1 cobas® HBV/HCV/HIV-1 Control Kit cobas® NHP Negative Control Kit KIT COBAS 58/68/8800 NHP NEG RMC IVD KIT COBAS 58/68/8800 HBV/HCV/HIV RMC IVD Analyzer for Clinical Use, Various Lightcycler Products AVL 9180 ELECTROLYTE ANALYZER ELECTRODE ISE CHLOR STARLYTE III, [AW] AVL K+ ELECTRODE AVL CA++ ELECTRODE ELECTRODE, ISE, POTASSIUM CALCIUM-ELECTRODE - ALFA WASSERMANN ELECTRODE, ISE, CHLORIDE ELECTRODE, ISE REF, STARLYTE III, [AW] AVL NA+ ELECTRODE REF.-ELECTRODE - ALFA WASSERMANN ELECTROLYTE ANALYZER W/O STARTERKIT 9180 AVL LI+ ELECTRODE SYSTEM, GENERIC, 9180 ELECTRODE, ISE, POTASSIUM, [ALFA W] LITHIUM-ELECTRODE - ALFA WASSERMANN Cl-ELECTRODE- ALFA WASSERMANN POTASSIUM-ELECTRODE - ALFA WASSERMANN ELECTRODE, ISE, SODIUM, [ALFA W] SODIUM-ELECTRODE - ALFA WASSERMANN AVL CL- ELECTRODE cobas 6800 System cobas 8800 System cobas HBV/HCV/HIV-1 Control Kit (HPC and LPC) in cassettes cobas HBV assay specific analysis package (ASAP) software Specimen preparation reagents (cobas omni Reagents) cobas NHP Negative Control Kit in cassettes cobas HBV in cassettes SW cobas HBV ASAP Software KIT COBAS 58/68/8800 HBV 192T IVD cobas® HBV cobas 4800 Cdiff Controls and Cofactor Kit, 10 Runs KIT COBAS 4800 CDIFF CONTROL IVD cobas 4800 Cdiff Amplification/Detection Kit, 240 Tests cobas 4800 Cdiff Amplification/Detection Kit, 80 Tests Anti-SARS-CoV-2 S CS Elecsys Anti-SARS-CoV-2 S Elecsys cobas e 200 Anti-SARS-CoV-2 S Elecsys E2G 300 Anti-SARS-CoV-2 S CC5 Elecsys Anti-SARS-CoV-2 S PC Elecsys KIT COBAS 6800/8800 SARS-COV-2 192T cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® 6800/8800 Systems KIT COBAS 6800/8800 SARS-COV-2/FLU RMC KIT COBAS 6800/8800 SARS-COV-2 480T KIT COBAS 6800/8800 SARS-COV-2/FLU 384T KIT COBAS LIAT SARS-COV-2/FLU CTL KIT COBAS 6800/8800 SARS-COV-2 RMC cobas® SARS-CoV-2 & Influenza A/B Control Kit cobas® SARS-CoV-2 Quality Control Kit KIT COBAS LIAT SARS-COV-2/FLU cobas® SARS-CoV-2 - 480T KIT C68/88 SARS-COV2 DUO RMC KIT C68/88 SARS-COV2 DUO 192T KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T KIT COBAS 58/68/8800 SARS-COV-2/FLU RMC KIT COBAS 4800 HSV 1/2 CONTROLS IVD KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD cobas Cdiff Nucleic acid test for use on the cobas Liat System KIT COBAS LIAT CDIFF IVD cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System KIT COBAS LIAT CDIFF Controls cobas Synergy labeled Master Dongle Box cobas Synergy labeled Terminal Dongle Box cobas e 801 immunoassay Analyzer cobas e 801 module OS Win10 Recovery USB c8000 DM Update USB-Stick USB 3 32GB Cobas 8000 OS Win10 Recovery USB c8000 DM Migration cobas 6800 instrument cobas 8800 instrument KIT COBAS 6800/8800 BUFF NEG RMC IVD KIT COBAS 6800/8800 UTIL CHAN 96T IVD Digital LightCycler® Analyzer Digital LC Analyzer cobas 5800 instrument LightCycler PRO, 96 Digital LC Partitioning Engine LightCycler PRO, 384 KIT COBAS 58/68/8800 BUFF NEG RMC KIT COBAS 6800/8800 BKV 192T IVD KIT COBAS 6800/8800 EBV/BKV RMC IVD cobas® BKV cobas® BKV for use on cobas® 6800/8800 Systems cobas® EBV/BKV Control Kit cobas transfer - RRF Heam,Coag 10 cobas bge link cobas Academy cobas IT 1000 c8100 PXT c8100 CLW c8100 TLJ c8100 SLL c8100 Type Alpha cobas 8100 OBS cobas 8100 ACU c8100 RFX c8100 Model Beta cobas 8100 connection kit cobas 8100 URF . c8100 SCM cobas 8100 RSF c8100 CLO Universal Connection Unit Bulk Loader for cobas p 471 Laser LLD centrifuge unit cobas connection module c8100 Beta c8100 SLR Aliquot Tip Loader cobas 8100 AOB c8100 CRW cobas 8100 BCL turn unit conveyor unit c8100 BCL cobas 8100 Model Alpha cobas 8100 BCL - FBT Modification kit cobas 8100 Signal Tower c8100 BRF Sorting System cobas p312(Kolibri) Bulk Loader Module for p512/612 LASER LLD INCL QSI/TTI cobas p501/p701 c8100 CRO Liquid Level Detection UPGR Kit cobas p701 cobas p 512 System Software cobas p 612 system cobas p671 output unit CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE cobas 8100 RSS Roche cobas Liat Module- IT 1000 Bi-directional driver STD INSTR P671 TTI W/O BC READ UN 115V p501/p701 Systems STD INSTR P471 TTI W/O BC READ UN 115 PComm ver 1.12.11 cobas Infinity v2.2.3 RSD Systems 770-1-CCM-AOB v1.1 VS Systems CCM AOB sw ver 13 cobas Infinity v2.3.3 SW COBAS P 312 VERSION 1.1.1 SW PATCH_P312_1.1.3_UPD.TAR.BZ2 STD INSTR P612 LASER LLD QSI REC w/o CCM Online Adapter 1.5 cobas Infinity v2.3.2 STD INSTR P671 TTI BC READING UN 115V cobas Infinity v2.2.1 COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM RSA Systems cobas8800B cobas p471 STD INSTR P471 TTI BC READING UNIT 115V cobas infinity sw v2.5.3 CLAS Systems cobas infinity MPA Systems cobas Infinity 3rd Party Drivers IT 1000 Operator Data driver ver. 1.1.2 HemoCue 201DM Glu RT module STD INSTR P612 LASER LLD QSI 3HHT CCM 713-2-cobase 8100 v1.5 CoaguChek Link Tier 1 cobas Infinity v2.2 IT 1000- PCOmmunicator .bat file 579-2-RSA Dynamic Interface v1.1 c8100 SW 03-09 cobas Infinity v2.2.2 c8100 Wright Patterson Air Force Base US cobas IT 1000 i-STAT/DE module HemoCue 201DM Glu module Coaguchek Link cobas infinity insights license PComm ver. 1.12.12 with script_1.12.13 MPA EVO Analycer connection Host CIT1k 3.9 CoaguChek Link Tier 2 Comm Server 1.11.3725 BCM for cobas 8100 Driver Framework 3.1.8915 Power Supply Unit cobas Infinity sw v2.5.1 cobas infinity POC IT solutions IT 1000 All in one installer STD INSTR P512 LASER LLD QSI REC w/o CCM cobas infinity core license cobas IT 1000 Operator Sync CoaguChek Link Tier 3 Piccolo Xpress module cobas p 501/ p 701 system software CCM cobas c 513 Connection Unit Linear Buffer Unit HemoCue 201DM Hb module cobas p 501/701 System Software CCM Address Extension Unit Data Innovations Instrument Manager Modular Connection Unit cobas infinity sw v317 Cobas 6000 Connection Unit CONVEYOR 2 Unit CONVEYOR 4 Unit SW c8000 data manager 168 HST Connection Unit Add-On Buffer Unit NAVIFY Remote Monitor OUTPUT UNIT Cobas 8000 Connection Unit CONVEYOR 3 Unit CONVEYOR 1 Unit CCM Bidirectional Interface TURN UNIT cobas Infinity Central Lab CCM Backend Connection Unit cobas 8100 System Software cobas BLIM for p471/p671/BCM cobas BLIM for p512/p612 ConKit cobas BLIM to p x71 B-Gate Interface cobas p 512 system cobas infinity POC CCM Vertical Overhead Conveyor Unit (1m) cobas transfer - RRF Urine 10 CD SYSTEM SW p 612 SP 2.1.1 navify® Lab Operations Accu-Chek Care cobas infinity POC remote access CCM Vertical Turntable Unit Accu-Chek 360° Diabetes Management System Professional CCM Vertical Power Box Unit Universal Connection Module (UCM2) CD SW multilingual_software_2.1.1 CD SYSTEM SW p 512 SP 2.1.1 navify POC Operations Accu-Chek Care (HCP) Kidney KFRE Algorithm navify Quality Control CCM Vertical Elevator Unit Accu-Chek Smart Pix Software cobas transfer - RRF Coag 5 cobas p 501 Post-Analytical Unit cobas p (701) POST ANALYTICAL COBAS TaqMan 48 Analyzer COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST cobas® liat CT, NG and MG control kit cobas® liat CT/NG nucleic acid test KIT COBAS LIAT CT/NG IVD cobas® liat CT/NG/MG nucleic acid test KIT COBAS LIAT CT/NG/MG IVD KIT COBAS LIAT CT/NG/MG CTL IVD SW USB COBAS LIAT CT/NG/MG V1.8 SW USB COBAS LIAT CT/NG V1.1 cobas p 680 Instrument cobas® 8800 System cobas Influenza A/B & RSV Quality Control Kit cobas Liat Influenze A/B & RSV KIT COBAS LIAT INFLUENZA A/B & RSV CTL KIT COBAS LIAT FLU A/B & RSV US-IVD cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System SW USB COBAS LIAT INFLUENZA RSV cobas Liat System cobas Influenza A/B Quality Control Kit for use on the cobas Liat System cobas c 70X AST/740 ISE CHLORID ELEKTR. cobas c 111 system ISE REFERENCE SOL. cobas c 111 system Aspartate Aminotransferase (AST)(S GOT) cobas C (111) CHLORIDE ELECTRODE ISE ISE Chloride Electrode ISE CALIBRATION KIT cobas c 111 system cobas C (111) SODIUM ELECTRODE ISE ISE Potassium Electrode cobas C (111) GLUCOSE Glucose 400T cobas c 111 ISE Sodium Electrode cobas C (111) AST AST/GOT 400T cobas c 111 C-Reactive Protein ISE SODIUM ELECTR. cobas c 111 system ISE CALIB. IND./URINE cobas c 111 system CRP HS 100T cobas c111 ASTPM, 740Tests, cobas c 701 cobas C (111) POTASSIUM ELECTRODE ISE ISE POTASSIUM ELECTR. cobas c 111 system Glucose HK COBAS C 111 ANALYZER Roche cobas Liat Module cobas Influenza A/B Nucleic acid test for use on the cobas Liat system cobas Liat system SW USB Cobas Liat Core V3.3 cobas® Liat®System Software v3.3 cobas b 123 SENSOR CART. BG/ISE/GLU/LAC cobas b 123 FLUID PACK 400 TESTS cobas b 123 FLUID PACK COOX 400 cobas b 123 FLUID PACK 700 cobas b 123 FLUID PACK 200 cobas b 123 FLUID PACK COOX 700 KIT COBAS 6800/8800 CMV RMC IVD SW COBAS CMV ASAP CD KIT COBAS 6800/8800 CMV 96T IVD KIT COBAS 58/68/8800 CMV 192T IVD cobas® CMV COBAS EPLEX CORE UNIT cobas eplex cobas p630 Application Software cobas p 480 Application Software cobas p 480 instrument cobas p 630 instrument cobas p 680 instrument cobas p 680 Application Software cobas® prime Universal Tray cobas® prime Pre-analytical System KIT COBAS PRIME UWRB IVD cobas® prime User Workflow Reagent Bottle (UWRB) cobas® prime Process Plus Module cobas® prime Tip Rack Tray cobas® prime Secondary Tube Tray AVENIO Edge System Ariosa Tecan Library Robot Ariosa Tecan Detection Robot AcfS Detection Robot AcfS Library Robot AcfS L&D Equipment Installation Bundle COBAS U411 TEST SYSTEM cobas u411 Chemstrip 10 UA cobas u 411 Urine Analyzer cobas MRSA/SA Test cobas 4800 system SW C4800 2.1 MRSA/SA AP V1.1 CD KIT COBAS4800 MIXEDBATCH LYSIS1 240T IVD cobas 4800 MRSA/SA Amplification/Detection Kit, 80 Test cobas 4800 MRSA/SA Amplification/Detection Kit, 240 Tests KIT COBAS 4800 MRSA/SA AMP/DET 80T IVD KIT COBAS 4800 MRSA/SA CONTROLS IVD KIT COBAS 4800 MRSA/SA AMP/DET240T IVD KIT COBAS 4800 MIXEDBATCH INT CTRL 1 IVD cobas 4800 MRSA/SA Controls and Cofactor Kit, 10 Runs KIT COBAS4800 MIXEDBATCH LYSIS1 960T IVD SOL, SODIUM ELECTRODE CONDITION, 125 ML cobas p 680 START-UP KIT MagNA Pure 24 Tip Park/Piercing Tool MagNA Pure 24 Piercing Tool MagNa Pure Compact Drip Tray MagNa Pure Lyser Rotor Lightcycler 2 Centrifuge MPLC CB, Reaction Tubes MP Compact Waste Tank MagNa Pure Compact Drop catcher Lightcycler O-Ring Cell Set cobas C311 AVENIO MILLISECT System SW cobas omni UCT 3.1 Lightcycler Color Compensation Set MagNa Pure RXN TIPS-LARGE Clot Catcher Pro [100 PCS] MagNa Pure LC Cool Block, Sample Carousel PC/CC-CUPS MagNa Pure Compact Tube Rack MPLC CB, 96-well PCR Plate MagNa Pure REAGENT TUB LID (Large) MagNa Lyser 115V MagNa Pure Waste accessories MagNa Pure Compact Cartridge Rack MagNa Pure LC 2 Instrument LIGHTCYCLER CLASSIC ROTOR UPGRADE KIT CLOT CATCHER [250 PC] MagNa Pure Compact Elution Tube Rack MPLC Reaction Tip (small) MPLC Greasing Set MPLC Reagent Tub (SMALL) MagNa Pure 96 Waste Rack IVD MPLC TUB LID (Small, Medium) Avenio Millisect System 2 MPLC Tub Lid (Large) MPLC O-Ring Maintenance Kit CONA, 100Tests, cobas c503 MagNa Pure 96 Reagent Rack IVD MPLC TUB LID SEAL Carry-over Needle Assessment MagNa Pure 96 Purification Rack IVD ISD Sample PT Elecsys cobas e 100 MagNa Pure Liquid Waste Funnel REFERENCE ELECTRODE ISE 91XX cobas Omni Processing Plate MICRO ELECTRODE REF MagNa Pure 96 Processing Plate cobas Omni Pipette Tips Instrument Check cobas Omni Amplification Plate MagNa Pure 96 Processing Cartridge MagNa Pure 96 Output Plate AssayTip/AssayCup tray ControlSet Vials Elecsys,cobas e LIGHTCYCLER ACCESSORIES CalSet Vials Elecsys,cobas e MagNA Pure 96 Dropcatcher IVD MAGNAPURE ACCESSORIES cobas x480 system cobas z480 system cobas HPV Test cobas z480 Analyzer cobas 4800 System Wash Buffer Kit, 960 Tests cobas Sample Prep Buffer cobas 4800 System cobas HPV AP software cobas 4800 System Sample Preparation Kit, 240 Tests SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD cobas 4800 HPV Amplification/Detection Kit, 960 Tests KIT cobas 4800 HPV CONTROLS 10 SETS IVD KIT cobas 4800 HPV AMP/DET 240T US-IVD KIT cobas 4800 SYS WASH BUFFER 960T IVD cobas 4800 HPV Controls Kit, 10 Sets KIT cobas 4800 SYS SAMPLE PREP 240T IVD KIT cobas 4800 SYS WASH BUFFER 240T IVD cobas 4800 System Wash Buffer Kit, 240 Tests KIT cobas 4800 SYS SAMPLE PREP 960T IVD KIT cobas 4800 SYS LIQ CYT PREP 960T IVD cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests SW C4800 HPV AP v2.1 CD KIT COBAS SAMPLE PREP BUFFER 480T IVD KIT cobas 4800 SYS LIQ CYT PREP 240T IVD KIT cobas 4800 HPV AMP/DET 960T US-IVD cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests cobas 4800 HPV Amplification/Detection Kit, 240 Tests cobas 4800 System Sample Preparation Kit, 960 Tests SW COBAS 4800 FSE TOOLS CD 3 SW cobas 4800 UDF v2 CD MICRO ELECTRODE NA+ MICRO ELECTRODE CA++ AUTO QC MODUL cobas b 221=Roche OMNI S MICRO ELECTRODE PH AVL MSS CASSETTE GLU/LAC/UREA cobas b 221<6>=Roche OMNI S6 system MICRO ELECTRODE CL MSS CASSETTE GLU MICRO ELECTRODE K+ cobas b 221<2>=Roche OMNI S2 system MICRO ELECTRODE PO2 AVL MSS CASSETTE GLU/LAC cobas b 221<4>=Roche OMNI S4 system MICRO ELECTRODE PCO2 AVL cobas b 221 <2> Roche OMNI S2 system cobas b 221 <6> Roche OMNI S6 system PreClean M Elecsys,cobas e MPLC RNA Isol.Tissue Lysis Buffer Refill ProCell M 2x2 L Elecsys,cobas e MagNA Pure LC tNA Isol. Kit HP Ionify SysR S3 cobas i 1x1L MPLC DNA Isol. Kit III (Bacteria) LC FS DNA Master^PLUS HY-Pb, 96 react. MagNA Pure DNA Tissue Lysis Buffer LC Control Kit DNA Ionify SysR CS cobas i 1x1L MPLC Tub Lid (small, medium) dGTP, PCR Grade Cleaner Basisch cobas c111 NucleoMix, 25mmol/l, 0.6 ml, GPR EcoTergent Ionify SysR VB1 cobas i 4x500ml Ionify System Reagent CS (iSysR CS) Ionify System Reagent VB1 (iSysR V1) Ionify AxisSol cobas i 1x500ml Ionify System Reagent S2 (iSysR S2) Ionify Pretreatment Whole Blood (iPTWB) Ionify System Reagent S1 (iSysR S1) LC HSV 1/2 Template DNA LC QC Kit Activator for cobas c,Integra,c111 LC CD Manual complete SW 4.1 dCTP,PCR Grade Di-Na solution COBAS INTEGRA ISE ETCHER 6 x 11ML MPLC Total Nucleic Acid Isolation Kit ECL-LC, BV-DILUENT, 250ml LC Uracil-DNA Glycosylase ISE ETCHER cobas c 111 system LC Control Kit RNA MPLC RNA Isol. Kit High Performance ISE DEPROTEINIZER cobas c 111 system HITACHI ISE 1N KCL ELECT SOLUTION 1L Terminal Transferase,recombinant (8000U) NACl 9% SI Gen.2, cobas c, Integra Sys Wash Elecsys,cobas e cobas Integra Cleaner MPLC mRNA Isol. Kit I - Lysis Buf.Refill CleanCell Elecsys,cobas e HP Viral Nucleic Acid Buffer Set CLEANING SOLUTION 988-4 (125 ML) S.E.T.S. NaOH-D, cobas c HP Viral Nucleic Acid Kit SODIUM ELECTRODE CONDITIONER (125 ML) MPLC mRNA HS Kit RealTime ready RNA Virus Master HP PCR Template Preparation Kit MPLC Waste Bag Universal Diluent 2x36ml Elecsys,cobas e SMS Solution for HIT 917 RINSE ADDITIVE SOLUTION (100x1 ML) ECL-LC, BV-STORE, 250ml Uracil-DNA Glycosylase,Heat-labile,100 U URINE DILUENT (500 ML) MPLC Total NA Isolation Kit-Large Volume ECL-LC, BV-SANITIZE, 100ml Uracil-DNA Glycosylase,Heat-labile,500 U MPLC DNA Isol. Kit I Probe Wash M Elecsys,cobas e cobas C SPECIAL CELL CLEANING SOLUTION ECL-LC, BV-CLEAN Plus, 1000ml MPLC Processing Cartridges PCR-M Elution Buffer 50mM pH 8,1, MBF NaOH-D, cobas c 701 Sample Cleaner 2, cobas 8000 DEPROTEINIZER (125 ML) MPLC DNA Isol. Kit Large Volume SMS, cobas c Sample Cleaner 2, cobas 6000 Cell Check Elecsys,cobas e MPLC Reaction Tip (large) CLEANING SOLUTION FOR AVL COMPACT II SET STREPTAVIDIN PHYCOERYTHRIN 1mL LUO SMS, cobas c 701 GC-RICH PCR System 2.2 KU PCR ENZYME, CUSTOM SQNM dTTP, PCR Grade, 125 umol PCR Buffer (10x) with MgCl2 GPR dUTP, PCR Grade, 25 umol LC FS DNA MasterPLUS HP, 100 ul PCR Enzyme, custom SQNM 1250 units dUTP,PCR Grade Di-Na Solution 4x125 uM LC Capillaries (100 ul) Phosphatase,alkaline(AP),MB Grade(1U/ul) Phosphatase,alkaline(AP),MB grd.(20U/ul) dCTP,PCR Grade Di-Na Solution 4x125 uM ELECSYS SAP BUFFER SAP Test Elecsys,cobas e LIGHTCYCLER MULTIPLEX DNA MASTER, 1000 rx dATP,PCR Grade Di-Na Solution 4x125 uM LightCycler Capillaries 100ul,M-grade dTTP,PCR Grade Di-Na Solution 4x125 uM Cell Wash Solution I/NaOH-D 2x1.9L LIGHTCYCLER MULTIPLEX DNA MASTER, 200 rx dTTP, PCR Grade, 25 umol LC EvoScript RNA Probes Master (200) ultraView Alkaline Phosphatase Red ISH Detection Kit VENTANA HE 600 Coverslip Activator EZ Prep Concentrate (10X) VENTANA HE 600 Cleaning Solution ULTRA LCS (Predilute) BenchMark Special Stains Deparaffinization Solution (10X) MagNA Pure 24 MGP set VENTANA HE 600 Differentiating Solution ISH Amplification Kit VENTANA HE 600 Wash VENTANA HE 600 Bluing LightCycler EvoScript RNA Probes Master, 200 Reactions LightCycler EvoScript RNA SYBR Green Master 200 HybReady Solution Hemolyzing reagent f.TQ HBA1c,cobas c513 LightCycler EvoScript RNA Probes Master, 1000 Reactions LCS (Predilute) LC EvoScript RNA SYBR Green Master 1000 LightCycler EvoScript RNA SYBR Green Master 1000 Special Stains Vapor Extraction System Special Stains Cleaning Kit VENTANA HE 600 Organic Solution VENTANA ISH iVIEWBlue Detection Kit ultraView SISH DNP Detection Kit LC EvoScript RNA SYBR Green Master (200) Special Cell Cleaning Solution, c513 Clean Cell M 2x2L Elecsys, cobas e Antibody Dilution Buffer ISH Peroxidase Inhibitor Special Stains Heavy Metal Extraction System PreClean M G2 2x2L Elecsys E2G RNA Positive Control Probe ultraView SISH Detection Kit MagNA Pure 24 Total NA Isolation Kit VENTANA ISH iVIEWBlue Plus Detection Kit ultraView Red ISH DIG Detection Kit KIT COBAS 6800/8800 HEV 96T CE-IVD Alu Positive Control Probe II ultraView Silver Wash II BenchMark Special Stains Liquid Coverslip ISH Negative Control ProCell M G2 2x2L Elecsys E2G Diluent MultiAssay E2G Diluent Universal E2G VENTANA HE 600 Transfer Fluid Acid wash Solution 2x2 L VENTANA BenchMark Special Stains Wash II S1 RINSE SOLUTION (2 PCS) cobas c 70x KCL/500 mL KIT ELECSYS CLEAN-CELL M 2X2 L Antigen Excess Reagent S3 FLUID PACK A (1 PC) CLEANING KIT for CL- ELECTRODE NaOH-D, 123Tests, cobas c503 Serum Index Gen.2 NACl 9% Dil, cobas c503, 123T PYP, 950T, cobas c 503 Special Cell Cleaning Solution EcoTergent, cobas c503 Special Wash Solution S2 FLUID PACK (1 PC) cobas® Sample Prep Buffer (CSPB) START, 1000T, cobas c 503 Eco Detergent SCCS, 50Tests, cobas c503 Acid Wash Solution Pyridoxal phosphate KIT COBAS PRIME SPEC PRE-EXTRACTION IVD ISE Reference Electrolyte, 2L SMS, cobas c503, 123T Hemolyzing reagent ISE Reference Electrolyte KIT COBAS PRIME PCR MEDIA IVD BASIC WASH 2x2 L NaCl or Sodium Chloride cobas® Specimen Pre-Extraction Reagent (SPER) NACl 9% SI Gen.2, 14500Tests, cobas c503 NaOH-D or Sodium Chloride Detergent cobas® PCR Media A1CD, cobas c 503 cobas® Sample Prep Buffer LC Multiplex RNA Virus Master, 200 LC Multiplex RNA Virus Master, 1000 SARS-CoV-2 Inactivation Solution UTM/VTM KIT COBAS PRIME SAMPLE PREP BUFFER IVD SARS-CoV-2 Inactivation Solution MagNa Pure 96 System Fluid cobas® Specimen Pre-Extraction Reagent cobas omni Utility Channel (192T) KIT COBAS 58/68/88 UTIL CHAN 192T IVD Benchmark Special Stains Cleaning Kit High Pure PCR Template Preparation Kit M-MLV RT, Mutante 3 Digital LightCycler® Partitioning Fluid Digital LightCycler® RNA Master Kit Digital LightCycler® DNA Master Kit High Pure Viral RNA Kit Ionify iPTReag2 cobas i Ionify SysR VB4 cobas i 1x500ml Ionify SysR S1 cobas i 4x500ml DNA AWAY Ionify Mass Axis Solution (iAxisSol) Ionify SysR VB2 cobas i 4x500ml Ionify Deproteinizer iDepro (6x21ML) Ionify Derivatization Reagent 1 (iDR1) Ionify System Reagent VB3 (iSysR V3) Ionify iDIL cobas i Ionify System Reagent S4 (iSysR S4) Ionify System Reagent VB4 (iSysR V4) Ionify SysR VB3 cobas i 4x500ml Ionify System Reagent VB2 (iSysR V2) Ionify iPTWB cobas i Ionify iPTReag1 cobas i HypoCleaner High PureViral Nucleic Acid Kit Ionify Pretreatment 1 (iPT1) Ionify SysR S2 cobas i 1x1L NaOH-D/Basic Wash 2x1,8 L LC FS DNA Master Hy.Pb, 480 react. cobas c 70X Internal Standard/2000 mL S.T.A.R. LC Multicolor Demo Set MP Bacteria Lysis Buffer dATP,PCR Grade Di-Na solution ISE DEPROTEINIZER cobas integra (6x21ML) ISE Int.Stand. Gen.2, cobas c, Hitachi Ionify System Reagent S3 (iSysR S3) MPLC Sample Cartridges LC Multiplex DNA Master HP Hitergent cobas c701 MPLC RNA Isol. Kit III Tissue NACl 9% Dil, cobas c HP Viral RNA Kit MagNA Lyser Green Beads MPC Nucleic Acid Isolation Kit I Sample Cleaner 1, cobas c Hitergent c311 cobas Integra Cleaner 150Tests MPLC Reagent Tub (small) MPC Nucleic Acid Isol. Kit I Large Vol. NaCL 9% cobas c 111 LightCycler Capillaries (20ul) 5x96 LC FS DNA Master Hy.Pb., 96 react. MPLC Disposable ISE Diluent Gen.2, 2x2 Liter Sample Cleaner 1, cobas 8000 MPLC Waste Bottle MPLC Cartridge Seal NACl 9% SI Gen.2, 3000Tests cobas c701 Elecsys SYSCLEAN MPLC DNA Isol.KitI-Lysis/Bind.Buf.Refill LC EBV Rec Template ProCell Elecsys,cobas e LC DNA Master Hy. Pb, 96 react. Ionify iDR1 cobas i Ionify SysR S4 cobas i 1x1L OMNI SOLUTION 2 (4x40 ML) NACl 9% Dil, cobas c 701 ISE Reference Electrolyte 500ML MPLC Reagent Tub (medium) LC RNA Master Hybridization Probes ECL-LC, BV-GLO Plus, 1000ml MPLC Tub Lid Seal S.E.T.S. II Kit High Pure Viral NA Large Volume Kit MPLC DNA Isol. Kit II (Tissue) NaOH-D / Basic Wash Terminal Transferase, recomb. (24 000 U) Diluent MultiAssay Elecsys,cobas e ISE Diluent Gen.2, cobas c, Hitachi dCTP,PCR Grade Di-Na slt cobas Integra NACl Diluent 9 % Ionify Diluent 1 (iDIL1) Ionify Deproteinizer (iDEPRO) MPLC totalNA Isol.Kit-Lysis/Bind.Buf.Ref LC FastStart Master Hyb Probes, M-Grade PCR Buffer without MgCl_2 , 10 x LC RNA Amplification Kit, Hyb. Probes CleanCell M 2x2 L Elecsys,cobas e cobas Integra FP Sample Dilution FLUID PACK S2 (1 PC) LC FS DNA Master^PLUS Hy.Pb, 480 react. MagNA Pure Compact RNA Isolation Kit BlankCell Elecsys,cobas e LC DNA Master Hy.Pb, 480 react. LC Strep B PTS1 GPR Acid wash Solution 2x1,8 L Hybridization Wash Buffer Kit Accelerator I 1 x 100ML Ionify Pretreatment 2 (iPT2) Kit Cobas Liat SARS-COV-S/FLU SARS-CoV-2 & Influenza A/B for use on the Liat System KIT COBAS LIAT STREP A 20 PACK W/PIPETT KIT COBAS LIAT STREP A CTL SW cobas NG ASAP 11.1 SW COBAS 6800/8800 0138.1011 SW cobas CT ASAP 11.1 KIT COBAS 6800/8800 CT/NG RMC IVD cobas® CT/NG for use on cobas® 6800/8800 systems KIT COBAS 6800/8800 CT/NG 480T IVD SW cobas CT/NG ASAP 11.1 cobas® CT/NG Positive Control Kit cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems KIT COBAS 58/68/8800 CT/NG RMC IVD KIT COBAS 58/68/8800 CT/NG 480T IVD cobas® PCR Urine Sample Kit cobas® PCR Media Uni Swab Sample Kit cobas® PCR Media Dual Swab Sample Kit KIT COBAS 6800/8800 EBV 192T IVD cobas EBV ASAP 11.1 cobas® EBV cobas® EBV ASAP version 11.1 COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2 COBAS TaqMan HIV-1 Test version 2 For Use With The High Pure System AMPLILINK Software Version 3.4 MagNA Pure 96 DNA and Viral NA Large Volume Kit MagNA Pure 24 Instrument MagNA Pure LC Instrument cobas x480 Instrument MagNA Pure 96 DNA Tissue Lysis Buffer MagNA Pure 96 External Lysis Buffer MagNA Pure 96 Plate Holder IVD MagNA Pure 96 Bacterial Lysis Buffer MagNA Pure 24 Protocol Set 1 MagNa Pure 96 Reagent Loop Unit IVD MagNa Pure 96 Bottle Rack IVD MagNA Pure 96 Bacterial Lysis Buffer IVD MagNA Pure 96 DNA and Viral NA SV Kit IVD MagNA Pure 24 Protocol Set v1.3 MagNA Pure 96 SW v3.1 MagNA Pure 96 Protocol Set 1 MagNA Pure 24 Protocol Set MagNA Pure 24 Protocols v1.4 MagNA Pure FFPET Buffer Set MagNA Pure 96 System Software Version 3.1.1 MagNA Pure 24 SW 1.1 MagNA Pure 96 Instrument FFPET Isolation Kit cobas 8000 C 502 MODULE Tina-quant IgA Gen.2 cobas 8000 cobas ISE MODULE [DOUBLE] cobas 8000 CORE UNIT cobas 8000 cobas C 701 MODULE ISE Indirect Na, K, Cl for Gen.2 cobas 8000 e 602 MODULE cobas 8000 c702 MODULE cobas c502 Analyzer cobas 8000 Data Manager cobas c702 Analyzer SCISE ISE Compensator cobas 8000 ISE Module cobas e602 Analyzer Self-Contained ISE Support Box cobas c701 Analyzer cobas 8000 Core COBAS 8000 C 502 MODULE CU SW DM c8000 V165 cobas 8000 system software SW Install CD c8000 V06-05 cobas 8000 CORE UNIT CU cobas 8000 Modular Analyzer Series SW WIN10 (2015) MIGRAT. KIT C8000 RP5810 cobas 8000 data manager

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Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)