BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ROCHE MOLECULAR SYSTEMS, INC.

    Reg #: 3004141078 · FEI: 3004141078 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    576
    Establishment Types
    2
    Classifications
    35

    Registration Details

    Registration Name
    ROCHE MOLECULAR SYSTEMS, INC.
    Registration Number
    3004141078
    FEI Number
    3004141078
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4300 HACIENDA DRIVE
    City
    PLEASANTON
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243863
    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
    Automated Radiological Image Processing Software QIH
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Respiratory Specimen Nucleic Acid Sars-Cov-2 Test QQX
    Instrumentation For Clinical Multiplex Test Systems NSU
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Dna-Reagents, Neisseria LSL
    Real Time Nucleic Acid Amplification System OOI
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus MZP
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Bordetella Pertussis Dna Assay System OZZ
    Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings QWR
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen NQX
    Cytomegalovirus (Cmv) Dna Quantitative Assay PAB
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Somatic Gene Mutation Detection System OWD
    C. Difficile Toxin Gene Amplification Assay OZN
    Test, Hiv Detection MZF
    Hepatitis Viral B Dna Detection MKT
    General Purpose Reagent PPM
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Clinical Sample Concentrator JJH
    Herpes Simplex Virus Nucleic Acid Amplification Assay OQO
    Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna QMI
    Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices QLT
    Station, Pipetting And Diluting, For Clinical Use JQW
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Test, Equipment, Automated Bloodborne Pathogen MZA
    Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna QLX
    Reagents, Monkeypox Virus Nucleic Acid. QTP
    Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test QST
    Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test QUM
    Culture-Based Short-Term Incubation Antimicrobial Resistance Assay QIV
    Kit, Dna Detection, Human Papillomavirus MAQ

    Proprietary Names

    Opulus Lymphoma Precision 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 cobas® SARS-CoV-2 Qualitative Control Kit cobas® SARS-CoV-2 Qualitative 480T cobas® SARS-CoV-2 Qualitative 192T 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 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 58/68/8800 HCV 192T IVD cobas® HCV Kit Cobas Liat SARS-COV-S/FLU SARS-CoV-2 & Influenza A/B for use on the Liat System KIT COBAS LIAT CT/NG/MG IVD KIT COBAS LIAT CT/NG/MG CTL IVD KIT COBAS LIAT CT/NG IVD 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 Cobas Liat SARS-COV-2 KIT COBAS LIAT SARS-COV-2 CTL 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 CT/NG Test For Use Only with cobas 4800 System Software Version 2.1 or Higher cobas z 480 Analyzer LightCycler version 1.2 Instrument 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 COBAS AmpliPrep/COBAS TaqMan CMV Test 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® 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 cobas z480 Analyzer cobas EGFR Mutation Test 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 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 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 cobas EGFR Mutation Test v2 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 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 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) 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 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 LightCycler version 2 Instrument LightCycler MRSA Detection Kit LightCycler Advanced Lysis Kit 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 DNA ISOLATION 24T IVD cobas BRAF V600 Mutation Test 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 6800/8800 Systems KIT COBAS 4800 HSV 1/2 CONTROLS IVD KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD 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 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 HIV-1 Specimen preparation reagents (cobas omni reagents) cobas HBV/HCV/HIV-1 Control Kit 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 COBAS TaqMan 48 Analyzer 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 KIT COBAS LIAT STREP A 20 PACK W/PIPETT KIT COBAS LIAT STREP A CTL KIT COBAS PCR MEDIA UNI SWB 100 PKT IVD cobas CT/NG Test, v2 SW c4800 CT/NG AP V. 2.1 CD cobas p 680 Instrument cobas® 8800 System KIT COBAS 6800/8800 EBV 192T IVD cobas EBV ASAP 11.1 cobas® EBV cobas® EBV ASAP version 11.1 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 68/8800 MPXV RMC KIT COBAS 68/8800 MPXV 192T KIT C68/88 HIV-1/HIV-2 QUAL 96T IVD cobas® HIV-1/HIV-2 Qualitative Control Kit cobas® HIV-1/HIV-2 Qualitative KIT COBAS 58/68/8800 HIV-1/2 192T IVD KIT COBAS 68/88 HIV-1/HIV-2 QUAL RMC IVD 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® 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 cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems COBAS TaqMan HBV Test For Use With The High Pure System COBAS AmpliPrep/COBAS TaqMan HBV Test, version 2 COBAS TAQMAN HBV TEST cobas KRAS Mutation Test cobas vivoDx MRSA Control Media cobas vivoDx system cobas vivoDx MRSA test cobas vivoDx MRSA Collection and Transportation Kit KIT COBAS 58/68/8800 BKV 192T IVD KIT COBAS 58/68/8800 EBV/BKV RMC IVD 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 cobas liat SARS-CoV-2 v2 nucleic acid test KIT C LIAT SARS COV2 V2 cobas® liat SARS-CoV-2 cobas® 6800 System KIT COBAS PCR MEDIA DUAL SWB 100 PKT IVD KIT CAP/CTM HCV v2 72T US-IVD cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test cobas liat CT/NG nucleic acid test 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, version 2 COBAS 4800 Test System KIT COBAS 58/68/8800 MPLX RESP FLEX PC IVD cobas Respiratory 4-flex KIT COBAS 58/68/8800 RESP 4-FLEX 192T IVD cobas Respiratory flex Control Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device