Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003795116

FEI Number

3003795116

Entity Name

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

City/State/Country

ROTKREUZ Zug, CH

Establishment Address

FORRENSTRASSE 2, ROTKREUZ Zug CH-6343, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Roche Diagnostics Operations Inc. (Owner Number: 9039767)

Owner / Operator Contact Address

9115 Hague Road, Indianapolis, IN 46250, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P100020

All Registered 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 HBV/HCV/HIV-1 Control Kit (HPC and LPC) in cassettes Specimen preparation reagents (cobas omni Reagents) cobas 6800/8800 Systems cobas NHP Negative Control Kit in cassettes 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-09-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-09-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2022-09-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2022-09-19
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2022-09-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-06-28
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2016-10-19
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-10-19
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2016-10-19
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2020-07-08
LGS	Fluorescence Polarization Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2008-05-30
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2008-05-30
DEL	Lipoprotein X, Antigen, Antiserum, Control	Immunology	Class 1	866.5590	2008-05-30
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2008-05-30
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2008-05-30
LGI	Fluorescence Polarization Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2008-05-30
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-05-30
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2008-05-30
JXO	Enzyme Immunoassay, Cocaine	Clinical Toxicology	Class 2	862.3250	2008-05-30
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2008-05-30
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-05-30
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2008-05-30
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-05-30
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2008-05-30
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-05-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-05-30
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2008-05-30
JHN	Turbidimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2008-05-30
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2008-05-30
CET	Olive Oil Emulsion (Turbidimetric), Lipase	Clinical Chemistry	Class 1	862.1465	2008-05-30
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2008-05-30
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2008-05-30
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-05-30
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-05-30
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2008-05-30
MOJ	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)	Clinical Toxicology	Class 2	862.3350	2008-05-30
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-05-30
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2008-05-30
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-05-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-05-30
LGQ	Fluorescence Polarization Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2008-05-30
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2008-05-30
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2008-05-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-05-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-05-30
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2008-05-30
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2008-05-30
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2008-05-30
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2008-05-30
JZW	Nephelometer	Immunology	Class 1	866.4540	2008-05-30
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-05-30
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2008-05-30
LBZ	Enzyme Immunoassay, Quinidine	Clinical Toxicology	Class 2	862.3320	2008-05-30
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-05-30
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2008-05-30
LPT	System, Test, Urinary Methylmalonic Acid	Clinical Chemistry	Class 2	862.1509	2008-05-30
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2008-05-30
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2008-05-30
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2008-05-30
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2008-05-30
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-05-30
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2008-05-30
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2008-05-30
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2008-05-30
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2008-05-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2008-05-30
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2008-05-30
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2008-05-30
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2008-05-30
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2008-05-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-05-30
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-05-30
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-06-17
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2016-10-19
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2008-06-12
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2010-02-16
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2010-02-16
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2010-02-16
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2010-02-16
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2010-02-16
MKT	Hepatitis Viral B Dna Detection	Microbiology	Class 2	866.3174	2016-01-22
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-10-19
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2016-10-19
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-23
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-04-23
OQO	Herpes Simplex Virus Nucleic Acid Amplification Assay	Microbiology	Class 2	866.3305	2016-10-19
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2017-09-28
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-09-28
PQQ	Data Acquisition Software	Clinical Chemistry	Class 2	862.2570	2017-07-11
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-03-22
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-03-22
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2017-09-05
QMI	Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna	Microbiology	Class 2	866.3183	2020-09-11
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2008-06-12
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2008-06-06
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2016-10-19
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2012-10-24
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2025-01-23
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2025-01-23
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2025-01-23
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2016-11-15
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2016-10-19
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-10-19
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-10-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-05-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-05-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-05-30
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2008-05-30
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2008-05-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-05-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2008-05-30
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2015-08-03
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2015-08-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-06-08
GGZ	Oxyhemoglobin	Hematology	Class 2	864.7500	2012-06-08
KHG	Whole Blood Hemoglobin Determination	Hematology	Class 2	864.7500	2012-06-08
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-06-08
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2012-06-08
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2012-06-08
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-06-08
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2012-06-08
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-06-08
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2012-06-08
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-06-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-06-08
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2012-06-08
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2017-06-12
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-04-18
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2002-04-17
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2010-05-19
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2010-05-19
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2010-05-19
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2010-05-19
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2010-05-19
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2010-05-19
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2010-05-19
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2010-05-19
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2010-05-19
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2010-05-19
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2010-05-19
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-10-19
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2016-10-19
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2010-06-28
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2001-04-23
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2012-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Frazier Business: Roche Diagnostics Operations Inc Email: brian.frazier@roche.com Phone: (317) 5214603

Related Public Records

Same Entity

Roche Diagnostics Operations Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010900203	Roche Diagnostics S.L.	Sant Cugat del Valles Barcelona, ES
3039321686	Roche Lumira Dx Stirling	Manor Loan Stirling, GB
3039322300	Roche Lumira Dx Bathgate	Bathgate Scotland, GB
3011806823	Roche Diabetes Care GmbH	Mannheim Baden-Wurttemberg, DE
3020917535	Roche Diagnostics (Suzhou) Ltd.	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25
K151792	Siemens Healthcare Diagnostics, Inc.	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	2015-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

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3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003795116. Last updated year: 2026. Please use registration number 3003795116 when referencing this establishment in official correspondence.