Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610529

FEI Number

3002806560

Entity Name

ROCHE DIAGNOSTICS GMBH

City/State/Country

PENZBERG Bavaria, DE

Establishment Address

NONNENWALD 2, PENZBERG Bavaria D-82377, DE

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

K951595

PMA Number

N/A

All Registered Proprietary Names

Elecsys Folate III CalSet Elecsys Folate III CalCheck ELECSYS FOLATE GEN 3 CALCHECK KIT Elecsys RBC Folate Hemolysing Reagent Elecsys PreciControl Anemia Elecsys Folate III Folate G3 CC 3 Elecsys Elecsys Folate gen 3 products Folate G3 CS Elecsys 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 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) 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 SW c8000 data manager 168 cobas 8000 data manager KIT DNA ISOLATION 24T IVD cobas BRAF V600 Mutation Test VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody FITC Anti-IgA Primary Antibody CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody anti-p40 (BC28) Mouse Monoclonal Primary Antibody CONFIRM anti-Melanosome (HMB45) Mouse Monoclonal Primary Antibody CONFIRM anti-Cytokeratin (AE1) Primary Antibody Endogenous Biotin Blocking Kit VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody anti-Cytokeratin 10 (SP99) Rabbit Monoclonal Primary Antibody CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody anti-Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody CONFIRM anti-Tyrosinase (T311) Mouse Monoclonal Primary Antibody VENTANA anti-E-Cadherin (36) Mouse Monoclonal Primary Antibo CONFIRM anti-CD23 (SP23) Rabbit Monoclonal Primary Antibody anti-Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (export) anti-CEA (TF 3H8-1) Primary Antibody CONFIRM anti-Synaptophysin (SP11) Rabbit Monoclonal Primary Antibody FITC Anti-Fibrinogen Primary Antibody CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody CONFIRM anti-Vimentin (Vim 3B4) Primary Antibody OptiView DAB IHC Detection Kit CONFIRM anti-Keratin (34?E12) Mouse Monoclonal Primary Antibody Anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody Anti-p53 (Bp53-11) Primary Antibody anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody FITC Anti-Albumin Primary Antibody OptiView Amplification Kit VENTANA PD-L1 (SP142) IHC Assay (export) CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody CONFIRM anti-CD68 (KP-1) Primary Antibody CONFIRM anti-p53 (DO7) Primary Antibody CONFIRM anti-Topoisomerase IIa (JS5B4) Rabbit Monoclonal Primary Antibody CONFIRM anti-S100 (4C4.9) Primary Antibody VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody anti-Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody VENTANA PD-L1 SP263 CONFIRM anti-Desmin (DE-R-11) Primary Antibody CONFIRM anti-LMO2 (1A9-1) Mouse Monoclonal Primary Antibody anti-CD30 (Ber-H2) Mouse Monoclonal Primary Antibody anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody CONFIRM anti-Lambda Rabbit Polyclonal Primary Antibody FITC Anti-C3 Primary Antibody CONFIRM anti-Epidermal Growth Factor Receptor (3C6) Primary Antibody anti-EGFR E746-A750 del (SP111) Rabbit Monoclonal Primary Antibody CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody FITC anti-Lambda Primary Antibody CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody Rabbit Monoclonal Negative Control Ig CONFIRM anti-Vimentin (V9) Primary Antibody VENTANA TFF3 (7F1.21) Mouse Monoclonal Primary Antibody CONFIRM anti-CD20 (L26) Primary Antibody FITC Anti-IgM Primary Antibody VENTANA PTEN (SP218) Rabbit Monoclonal Primary Antibody anti-bcl-2 (SP66) Rabbit Monoclonal Primary Antibody VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal (export) Bluing Reagent Melanoma Triple Cocktail (HMB45+A103+T311) Primary Antibody CONFIRM anti-ALK1 (ALK01) Primary Antibody anti-CD44 (SP37) Rabbit Monoclonal Primary Antibody CONFIRM anti-CD79a (SP18) Rabbit Monoclonal Primary Antibody Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody CONFIRM anti-MITF (C5/D5) Mouse Monoclonal Primary Antibody anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody FITC anti-C1q Primary Antibody CONFIRM anti-S100 (Polyclonal) Primary Antibody VENTANA Basal Cell Cocktail (34bE12+p63) CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody CONFIRM Anti-CD34 (QBEnd/10) Mouse Monoclonal Primary Antibody ultraView Universal DAB Detection Kit anti-p504s (SP116) CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody iVIEW DAB Detection Kit Anti-CD43 (L60) Mouse Monoclonal Primary Antibody CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody CONFIRM anti-p53 (DO-7) Primary Antibody VENTANA anti-p120 catenin (98) Mouse Monoclonal Primary Antibody Anti-Cytokeratin (CAM 5.2) Mouse Monoclonal Primary Antibody anti-MUC1 (H23) Mouse Monoclonal Primary Antibody FITC Anti-Kappa Primary Antibody VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody NeuVision Blocking Reagent CONFIRM anti-Thyroid Transcription Factor-1 (8G7G3/1) Mouse Monoclonal Primary Antibody VENTANA anti-Cyclin D1 (SP4-R) Rabbit Monoclonal Primary Antibody anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody ultraView Universal Alkaline Phosphatase Red Detection Kit CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody CONFIRM Negative Control Rabbit Ig FITC Anti-IgG Primary Antibody CONFIRM anti-HER-2/neu (4B5) Primary Antibody CONFIRM anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Antibody anti-ERG (EPR3864) Rabbit Monoclonal Primary Antibody VENTANA iView DAB Universal Kit (export) Amplification Kit CONFIRM anti-CD30 (Ber-H2) Primary Antibody VENTANA PD-L1 (SP263) Assay (export) Negative Control (Monoclonal) Anti-Chromogranin A (LK2H10) Primary Antibody Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody VENTANA Protease Neg Reagent Control-IVD VENTANA MSLN (SP74) ASSAY VENTANA pan-TRK (EPR17341) Assay VENTANA CLDN18 [43-14A] Assay Ventana ROS1 (SP384) Rb Mono Primary Ab anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody VENTANA Red ISH DIG Detection Kit ECL-LC CD117(EP10) Rabbit Monoclonal PAB VENTANA Silver ISH DNP Detection Kit RABBIT ANTI-DNP ANTIBODY CONFIRM anti-MSH6 (44) Mouse Monoclonal VENTANA U6 BF Probe VENTANA anti-AREG (SP272) Rabbit Monoclonal Primary Antibody ISH TSA Ancillary Kit VENTANA Silver ISH BF Detection Kit VENTANA FGFR2b (FPR2-D) Assay 1 PRAME (EPR20330) Rbt Mono PAB 250 PRAME (EPR20330) Rbt Mono PAB 50 CD8 (SP239) Rabbit Monoclonal PAB CONFIRM anti-Ki-67 (30-9) VENTANA Magenta ISH DIG Detection Kit INSM1 (SP493) Rabbit Monoclonal Primary Antibody VENTANA HER2 (CAL27) Assay VENTANA HA Assay VENTANA DLL3 (SP347) Assay ATRX CM Rabbit Polyclonal Antibody VENTANA ANTI-P63 (4A4) 250 IDH1 R132H (MRQ-67) CM Rabbit Monoclonal p40 (SP225) Rabbit Monoclonal PAB VENTANA anti-EREG (SP326) Rabbit Monoclonal Primary Antibody TRPS1 (SP532) Rabbit Monoclonal Antibody VENTANA U6 DIG Probe CONFIRM MART-1/melan A (A103) 250 test CD68 (SP251v18) Rabbit Monoclonal Antibody VENTANA MTAP (SP530) Rabbit Monoclonal Antibody VENTANA TROP2 (EPR20043) Rabbit Monoclonal Antibody Special Stains Congo Red Stain Core Kit PAX-8 (SP348) Rabbit Monoclonal Antibody VENTANA MTAP (SP530) Antibody 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-08-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-08-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-08-26
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2009-08-26
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2001-03-06
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2010-09-15
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2010-09-15
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2010-09-15
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2010-09-15
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2010-09-15
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2010-09-15
CJX	Acid Phosphatase, Disodium Phenylphosphate	Clinical Chemistry	Class 2	862.1020	2010-09-15
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2010-09-15
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2010-09-15
KXS	Radioimmunoassay, Methaqualone	Clinical Toxicology	Class 2	862.3630	2010-09-15
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2010-09-15
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2010-09-15
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2010-09-15
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2010-09-15
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2010-09-15
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2010-09-15
DAO	Igm (Mu Chain Specific), Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2010-09-15
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2010-09-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2010-09-15
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2010-09-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2010-09-15
CHN	Immunochemical, Ceruloplasmin	Immunology	Class 2	866.5210	2010-09-15
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2010-09-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2010-09-15
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2010-09-15
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2010-09-15
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2010-09-15
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Clinical Toxicology	Class 2	862.3560	2010-09-15
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2010-09-15
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2010-09-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2010-09-15
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2010-09-15
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2010-09-15
KLB	Radioimmunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2010-09-15
LBZ	Enzyme Immunoassay, Quinidine	Clinical Toxicology	Class 2	862.3320	2010-09-15
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2010-09-15
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2010-09-15
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2010-09-15
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2010-09-15
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2010-09-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2010-09-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2010-09-15
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2010-09-15
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2010-09-15
DLB	Radioimmunoassay, Lsd (125-I)	Clinical Toxicology	Class 2	862.3580	2010-09-15
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2010-09-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2010-09-15
OAV	Mycophenolic Acid Test System	Clinical Toxicology	Class 2	862.3840	2010-09-15
JGQ	Turbidimetric, Total Protein	Clinical Chemistry	Class 2	862.1635	2010-09-15
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2010-09-15
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2010-09-15
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2010-09-15
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2010-09-15
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2010-09-15
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2010-09-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-09-15
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2010-09-15
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2010-09-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2010-09-15
KLP	Amikacin Serum Assay	Clinical Toxicology	Class 2	862.3035	2010-09-15
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2010-09-15
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2010-09-15
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2010-09-15
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2010-09-15
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2010-09-15
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2010-09-15
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2010-09-15
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2010-09-15
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2010-09-15
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2010-09-15
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2010-09-15
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2010-09-15
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2010-09-15
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2010-09-15
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2010-09-15
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2010-09-15
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2010-09-15
DML	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2010-09-15
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2016-10-19
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2012-01-17
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

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
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2009	Roche Diagnostics Corp.	1	Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma.
Z-0012-2009	Roche Diagnostics Corp.	2	Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

Similar Registrations

Registration Number	Establishment Name	Location
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE
2122870	BECKMAN COULTER, INC.	CHASKA, MN, US
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 9610529. Last updated year: 2026. Please use registration number 9610529 when referencing this establishment in official correspondence.