BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ROCHE MOLECULAR SYSTEMS, INC.

    Reg #: 2243471 · FEI: 2243471 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    873
    Establishment Types
    3
    Classifications
    48

    Registration Details

    Registration Name
    ROCHE MOLECULAR SYSTEMS, INC.
    Registration Number
    2243471
    FEI Number
    2243471
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1080 US Highway 202 South
    City
    Branchburg
    State
    NJ
    ZIP
    08876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223783
    PMA Number
    P110037

    Owner / Operator

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

    Products

    Device Name Product Code
    Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices QLT
    Instrumentation For Clinical Multiplex Test Systems NSU
    Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings QWR
    Hepatitis Viral B Dna Detection MKT
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Cytomegalovirus (Cmv) Dna Quantitative Assay PAB
    Calculator/Data Processing Module, For Clinical Use JQP
    General Purpose Reagent PPM
    Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test QUM
    Real Time Nucleic Acid Amplification System OOI
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Test, Factor V Leiden Mutations, Genomic Dna Pcr NPQ
    Somatic Gene Mutation Detection System OWD
    Dengue Nucleic Acid Amplification Assay (Naat) OZB
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Test, Hiv Detection MZF
    Kit, Dna Detection, Human Papillomavirus MAQ
    Dna-Reagents, Neisseria LSL
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Bordetella Pertussis Dna Assay System OZZ
    Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test QST
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus MZP
    Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis NDZ
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen NQX
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Micro Pipette JRC
    Respiratory Specimen Nucleic Acid Sars-Cov-2 Test QQX
    Herpes Simplex Virus Nucleic Acid Amplification Assay OQO
    Station, Pipetting And Diluting, For Clinical Use JQW
    Culture-Based Short-Term Incubation Antimicrobial Resistance Assay QIV
    Babesia Spp. Serological Reagents QIN
    Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna QLX
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Elisa, Antibody, West Nile Virus NOP
    C. Difficile Toxin Gene Amplification Assay OZN
    Zika Virus Serological Reagents QFO
    Reagents, Monkeypox Virus Nucleic Acid. QTP
    Monitor,Test,Hiv-1 MTL
    Device, Specimen Collection LIO
    Device To Detect Antibodies To Hepatitis D Virus SGW
    Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna QMI
    Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System PQA
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Processor, Cervical Cytology Slide, Automated MKQ
    Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY
    Test, Factor Ii G20210a Mutations, Genomic Dna Pcr NPR

    Proprietary Names

    cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test cobas liat SARS-CoV-2, Influenza A/B & RSV control kit KIT C LIAT SARS COV2 FLU AB RSV KIT C LIAT SARS COV2 FLU AB RSV CTL 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 Liat SARS-COV-2 KIT COBAS LIAT SARS-COV-2 CTL KIT CAP-G/CTM HBV V2 72TESTS CE-IVD KIT COBAS 4800 HBV 120T CE-IVD cobas Liat system KIT COBAS LIAT STREP A 20 PACK W/PIPETT KIT COBAS LIAT STREP A CTL COBAS AmpliPrep/COBAS TaqMan CMV Test 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 KIT COBAS 4800 HXV CONTROLS 10T CE-IVD KIT COBAS 4800 HCV GT CTLS 10T CE-IVD KIT COBAS 6800/8800 HEV 96T CE-IVD KIT COBAS 6800/8800 DPX RMC CE-IVD KIT COBAS 6800/8800 HEV RMC CE-IVD HybClear Solution-US EXPORT KIT COBAS 6800/8800 DPX 96T CE-IVD KIT COBAS 4800 LYSIS 2 240T CE-IVD KIT C4800 HCV GT AMP/DET 120T CE-IVD KIT COBAS 58/68/8800 DPX 192T CE-IVD KIT COBAS 58/68/8800 HEV RMC CE-IVD KIT COBAS 4800 SAMPLE PREP 2 240T CE-IVD KIT COBAS 4800 SPEC DIL 2 240T CE-IVD KIT COBAS 58/68/8800 DPX RMC CE-IVD KIT COBAS 4800 HCV 120T CE-IVD KIT COBAS 58/68/8800 HEV 192T CD-IVD cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems KIT C58/68/8800 HIV1/HIV2 QUAL RMC IVD KIT COBAS 58/68/8800 HIV-1/2 192T IVD cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems Roche cobas Liat Module cobas Influenza A/B Nucleic acid test for use on the cobas Liat system SW USB Cobas Liat Core V3.3 cobas® Liat®System Software v3.3 KIT COBAS 4800 F2F5 AMP/DET 96T IVD cobas z480 Analyzer cobas EGFR Mutation Test KIT C68/88 CHIKV/DENV 480T CE-IVD KIT C58/68/88 CHIKV/DENV 480T CE-IVD KIT C68/88 CHIKV/DENV RMC CE-IVD KIT COBAS 58/68/88 CHIKV/DENV RMC CE-IVD KIT COBAS 6800/8800 TV/MG RMC IVD KIT COBAS 6800/8800 TV/MG 384T IVD KIT COBAS 58/68/8800 TV/MG 384T IVD KIT COBAS 58/68/8800 TV/MG RMC IVD KIT COBAS 68/88 SPECIMEN PRE-EXTRACT IVD COBAS 4800 HIV-1 QT-QL 120T CE-IVD KIT CAP-G/CTM HIV-1 v2 EXPT-IVD COBAS 58/68/8800 MPX RMC IVD KIT COBAS 6800/8800 MPX 480T CE-IVD COBAS 58/68/8800 MPX 480T IVD KIT COBAS 58/68/8800 MPX 192T CE-IVD cobas MPX-E 192T cobas MPX-E 480T cobas MPX-E Control Kit KIT COBAS 6800/8800 HPV 480T IVD KIT COBAS 6800/8800 HPV RMC IVD KIT COBAS 58/68/8800 HPV 480T IVD KIT COBAS 58/68/8800 HPV RMC IVD cobas CT/NG Test For Use Only with cobas 4800 System Software Version 2.1 or Higher cobas z 480 Analyzer cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test KIT COBAS LIAT BORDETELLA PANEL CTL IVD cobas liat Bordetella panel control kit KIT COBAS LIAT BORDETELLA PANEL IVD cobas liat Bordetella panel nucleic acid test KIT C68/88 HIV-1/HIV-2 QUAL 96T IVD KIT COBAS 68/88 HIV-1/HIV-2 QUAL RMC IVD cobas CT/NG Test, version 2 COBAS 4800 Test System KIT CAP/CTM HCV v2 72T US-IVD KIT CTM MTB 48T EXPT-IVD KIT COBAS 6800/8800 MTB RMC IVD KIT COBAS 6800/8800 MAI 384T KIT COBAS 6800/8800 MTB 384T KIT COBAS 6800/8800 MTB-RIF/INH 72T IVD KIT COBAS 6800/8800 MAI RMC IVD AMPLICOR® Respiratory Specimen Preparation Kit (100 Tests) KIT COBAS 6800/8800 MTB-RIF/INH RMC IVD KIT COBAS 58/68/8800 MAI 384T KIT COBAS 58/68/8800 MTB 384T KIT CTM48 MAI 96 TESTS JPN-IVD KIT COBAS 58/68/8800 MAI RMC IVD KIT COBAS 58/68/8800 MTB-RIF/INH 192T KIT COBAS 58/68/8800 MTB RMC IVD KIT COBAS 58/68/8800 MTB-RIF/INH RMC KIT C-TAQ MTB 96T JPN-IVD KIT COBAS 58/68/8800 HCV 192T IVD cobas® HCV cobas liat CT/NG nucleic acid test 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 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 58/68/8800 SARS-COV-2/FLU 384T cobas® SARS-CoV-2 & Influenza A/B KIT COBAS 58/68/8800 SARS-COV-2/FLU RMC KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T GM EPLEX RESP PATHOGEN 2 PANEL EUA KIT 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 LightCycler version 2 Instrument LightCycler MRSA Detection Kit LightCycler Advanced Lysis Kit KIT COBAS 4800 CMV CONTROLS 10T CE-IVD KIT COBAS 4800 CMV 120T CE-IVD Inline User Fillable Kit Prep Kit Light Protective Prep Kit NEXES REAGENT DISPENSER CARD ASSY RGT DISPENSER CARD ISH PROBE cobas® liat transfer pipette pack kit cobas® SARS-CoV-2 Qualitative Control Kit cobas® SARS-CoV-2 Qualitative 480T cobas® SARS-CoV-2 Qualitative 192T KIT COBAS 4800 HSV 1/2 CONTROLS IVD KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD KIT DNA ISOLATION 24T IVD cobas BRAF V600 Mutation Test COBAS EPLEX RESP PATHOGEN PANEL 3 12T KIT C68/88 UC INFLUENZA A/B RSV 192T IVD KIT C68/88 UC INFLUENZA A/B RSV PC IVD KIT COBAS 58/68/8800 MPLX RESP FLEX PC IVD KIT COBAS 58/68/8800 MPLX RESP FLEX 192T IVD cobas liat SARS-CoV-2 v2 nucleic acid test KIT C LIAT SARS COV2 V2 cobas® liat SARS-CoV-2 KIT COBAS PCRFEMALESWAB 100PKT JAPAN-IVD KIT COBAS LIAT CT/NG/MG IVD KIT COBAS LIAT CT/NG/MG CTL IVD KIT COBAS LIAT CT/NG IVD 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 vivoDx MRSA Control Media cobas vivoDx system cobas vivoDx MRSA test cobas vivoDx MRSA Collection and Transportation Kit KIT COBAS 58/68/8800 BABESIA RMC IVD KIT COBAS 58/68/8800 BABESIA 480T IVD KIT COBAS 6800/8800 BKV 192T IVD KIT COBAS 58/68/8800 BKV 192T IVD KIT COBAS 58/68/8800 EBV/BKV RMC IVD KIT CAP-G/CTM CMV 72 TESTS CE-IVD KIT COBAS 58/68/88 CMV DUAL 192T CE IVD KIT COBAS 58/68/88 CMV DUAL RMC IVD cobas® liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test KIT C LIAT SARS COV2 FLU AB V2 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 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 MPLC Greasing Set 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 MPLC Reaction Tip (small) 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 MPLC O-Ring Maintenance Kit 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) 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 KIT CAP/CTM HCV v2 QUAL CE-IVD KIT COBAS 6800/8800 UTIL CHAN 96T CE-IVD KIT CAP/CTM HIV-1 v2 QUAL CE-IVD KIT COBAS 6800/8800 HCV 96T CE-IVD KIT COBAS 58/68/8800 CMV RMC IVD KIT COBAS 6800/8800 MPX RMC CE-IVD 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 Reagent Tub (SMALL) MagNa Pure 96 Waste Rack IVD MPLC TUB LID (Small, Medium) Avenio Millisect System 2 MPLC Tub Lid (Large) 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 KIT COBAS 58/68/8800 WNV RMC IVD KIT COBAS 58/68/8800 WNV 192T CE-IVD KIT COBAS 6800/8800 WNV 480T 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 KIT COBAS 58/68/8800 ZIKA 480T IVD KIT COBAS 58/68/8800 ZIKA ARNA RMC IVD KIT COBAS 68/8800 MPXV RMC KIT COBAS 68/8800 MPXV 192T KIT COBAS PCR MEDIA DUAL SWB 100 PKT IVD KIT COBAS 6800/8800 HIV 96T IVD KIT COBAS 4800 CDIFF AMP/DET 240T CE-IVD KIT COBAS 4800 CDIFF AMP/DET 80T CE-IVD 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 KIT RMS PCR CELL MEDIA X250 VIALS CE-IVD KIT ROCHE CELL COLLECTION MEDIUM 20 ML 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® cfDNA Sample Preparation Kit KIT c4800 BRAF v600E AMP/DET 24T CE-IVD KIT COBAS 4800 PIK3CA AMP/DET 24T IVD LBLD Protienase K IVD cobas HDV cobas HDV Control Kit KIT COBAS 58/68/8800 HDV 192T IVD KIT COBAS 58/68/8800 HDV RMC IVD INFORM HPV III Family 16 Probe (B) INFORM HPV II Family 6 Probe KIT cobas 4800 HPV AMP/DET 960T CE-IVD KIT cobas 4800 HPV AMP/DET 240T CE-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 KRAS Mutation Test COBAS TaqMan HBV Test For Use With The High Pure System COBAS AmpliPrep/COBAS TaqMan HBV Test, version 2 COBAS TAQMAN HBV TEST cobas x480 system cobas z480 system cobas HPV Test 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 KIT COBAS 5800/6800/8800 BV/CV RMC IVD KIT COBAS 5800/6800/8800 BV/CV 192T IVD 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® HIV-1/HIV-2 Qualitative Control Kit cobas® HIV-1/HIV-2 Qualitative cobas® HIV-1/HIV-2 KIT C58/68/88 HIV-1/HIV-2 QUAL 192T IVD cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems KIT COBAS 58/68/8800 HIV-1/2 RMC 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 KIT DISPENSER FOR 945ML RCCM BOTTLE KIT ROCHE CELL COLLECTION MEDIUM 945ML 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 PCR Media Dual Swab Sample Kit (100 packets) KIT cobas 4800 CT/NG AMP DET 240T IVD cobas CT/NG Positive Control Kit cobas CT/NG 480 Tests Kit cobas PCR Media 100T IVD cobas PCR Media Uni Swab Sample Kit (100 packets) KIT cobas 4800 CT/NG AMP DET 960T IVD 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 cobas EGFR Mutation Test v2 Kit Cobas Liat SARS-COV-S/FLU SARS-CoV-2 & Influenza A/B for use on the Liat System cobas Respiratory 4-flex KIT COBAS 58/68/8800 RESP 4-FLEX 192T IVD cobas Respiratory flex Control Kit cobas® liat CT, NG and MG control kit cobas® liat CT/NG nucleic acid test cobas® liat CT/NG/MG nucleic acid test SW USB COBAS LIAT CT/NG/MG V1.8 SW USB COBAS LIAT CT/NG V1.1 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 KIT COBAS 6800/8800 TV/MG 480T IVD cobas® Factor II and Factor V Test SET CD-ROM C4800 F2F5 PCR V1

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    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only