ROCHE DIAGNOSTICS GMBH

Reg #: 9610529 · FEI: 3002806560 · Expires 2026

View on FDA

Products

109

Proprietary Names

550

Establishment Types

Classifications

109

Registration Details

Registration Name: ROCHE DIAGNOSTICS GMBH
Registration Number: 9610529
FEI Number: 3002806560
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: NONNENWALD 2
City: PENZBERG Bavaria
Country: DE

Regulatory Submissions

510(k) Number: K082340
PMA Number: P110020

Owner / Operator

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

US Agent

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

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2009-08-26
Multi-Analyte Controls, All Kinds (Assayed)	JJY	Class 1	Clinical Chemistry	No	2009-08-26
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2009-08-26
Acid, Folic, Radioimmunoassay	CGN	Class 2	Clinical Chemistry	No	2009-08-26
General Purpose Reagent	PPM	Class 1	Pathology	No	2001-03-06
Assay, Glycosylated Hemoglobin	LCP	Class 2	Hematology	No	2010-09-15
Enzymatic Method, Ammonia	JIF	Class 1	Clinical Chemistry	No	2010-09-15
Colorimetry, Cholinesterase	DIH	Class 1	Clinical Toxicology	No	2010-09-15
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	Class 2	Immunology	No	2010-09-15
System, Test, Beta-2-Microglobulin Immunological	JZG	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, N-Acetylprocainamide	LAN	Class 2	Clinical Toxicology	No	2010-09-15
Acid Phosphatase, Disodium Phenylphosphate	CJX	Class 2	Clinical Chemistry	No	2010-09-15
Acid, Uric, Uricase (Colorimetric)	KNK	Class 1	Clinical Chemistry	No	2010-09-15
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2010-09-15
Radioimmunoassay, Methaqualone	KXS	Class 2	Clinical Toxicology	No	2010-09-15
Iga, Antigen, Antiserum, Control	CZP	Class 2	Immunology	No	2010-09-15
Haptoglobin, Antigen, Antiserum, Control	DAD	Class 2	Immunology	No	2010-09-15
Albumin, Antigen, Antiserum, Control	DCF	Class 2	Immunology	No	2010-09-15
System, Test, C-Reactive Protein	DCN	Class 2	Immunology	No	2010-09-15
Colorimetry, Salicylate	DKJ	Class 2	Clinical Toxicology	No	2010-09-15
Cresolphthalein Complexone, Calcium	CIC	Class 2	Clinical Chemistry	No	2010-09-15
Igm (Mu Chain Specific), Antigen, Antiserum, Control	DAO	Class 2	Immunology	No	2010-09-15
Colorimetry, Acetaminophen	LDP	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2010-09-15
Transferrin, Antigen, Antiserum, Control	DDG	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Opiates	DJG	Class 2	Clinical Toxicology	No	2010-09-15
Immunochemical, Ceruloplasmin	CHN	Class 2	Immunology	No	2010-09-15
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2010-09-15
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	Class 2	Clinical Chemistry	No	2010-09-15
Enzymatic, Carbon-Dioxide	KHS	Class 2	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Valproic Acid	LEG	Class 2	Clinical Toxicology	No	2010-09-15
Assay, Porphyrin, Spectrophotometry, Lithium	NDW	Class 2	Clinical Toxicology	No	2010-09-15
Bromcresol Green Dye-Binding, Albumin	CIX	Class 2	Clinical Chemistry	No	2010-09-15
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	Class 1	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2010-09-15
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	Class 2	Clinical Chemistry	No	2010-09-15
Catalytic Methods, Amylase	JFJ	Class 2	Clinical Chemistry	No	2010-09-15
Radioimmunoassay, Tobramycin	KLB	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Quinidine	LBZ	Class 2	Clinical Toxicology	No	2010-09-15
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	Class 2	Clinical Chemistry	No	2010-09-15
Test, Cystatin C	NDY	Class 2	Clinical Chemistry	No	2010-09-15
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	No	2010-09-15
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Phenobarbital	DLZ	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2010-09-15
Fibrin Split Products	GHH	Class 2	Hematology	No	2010-09-15
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2010-09-15
Radioimmunoassay, Lsd (125-I)	DLB	Class 2	Clinical Toxicology	No	2010-09-15
Ferritin, Antigen, Antiserum, Control	DBF	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2010-09-15
Mycophenolic Acid Test System	OAV	Class 2	Clinical Toxicology	No	2010-09-15
Turbidimetric, Total Protein	JGQ	Class 2	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Digoxin	KXT	Class 2	Clinical Toxicology	No	2010-09-15
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	Class 1	Clinical Chemistry	No	2010-09-15
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	Class 2	Clinical Chemistry	No	2010-09-15
Radioimmunoassay, Vancomycin	LEH	Class 2	Clinical Toxicology	No	2010-09-15
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	Class 2	Immunology	No	2010-09-15
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2010-09-15
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2010-09-15
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2010-09-15
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2010-09-15
Amikacin Serum Assay	KLP	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Diphenylhydantoin	DIP	Class 2	Clinical Toxicology	No	2010-09-15
Acid, Lactic, Enzymatic Method	KHP	Class 1	Clinical Chemistry	No	2010-09-15
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2010-09-15
Alpha-1-Lipoprotein, Antigen, Antiserum, Control	DER	Class 2	Immunology	No	2010-09-15
Complement C3, Antigen, Antiserum, Control	CZW	Class 2	Immunology	No	2010-09-15
System, Test, Low Density, Lipoprotein	MRR	Class 1	Clinical Chemistry	No	2010-09-15
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	No	2010-09-15
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2010-09-15
Bromcresol Purple Dye-Binding, Albumin	CJW	Class 2	Clinical Chemistry	No	2010-09-15
Complement C4, Antigen, Antiserum, Control	DBI	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Propoxyphene	JXN	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Theophylline	KLS	Class 2	Clinical Toxicology	No	2010-09-15
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	Class 2	Immunology	No	2010-09-15
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2010-09-15
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2010-09-15
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Procainamide	LAR	Class 2	Clinical Toxicology	No	2010-09-15
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method	DML	Class 2	Clinical Toxicology	No	2010-09-15
Somatic Gene Mutation Detection System	OWD	Class 3	Unknown	No	2016-10-19
Immunohistochemistry Reagents And Kits	NJT	Class 1	Hematology	No	2012-01-17
Fluorescence Polarization Immunoassay, Theophylline	LGS	Class 2	Clinical Toxicology	No	2008-05-30
Lipoprotein X, Antigen, Antiserum, Control	DEL	Class 1	Immunology	No	2008-05-30
Fluorescence Polarization Immunoassay, Carbamazepine	LGI	Class 2	Clinical Toxicology	No	2008-05-30
Enzyme Immunoassay, Cocaine	JXO	Class 2	Clinical Toxicology	No	2008-05-30
Turbidimetric Method, Lipoproteins	JHN	Class 1	Clinical Chemistry	No	2008-05-30
Olive Oil Emulsion (Turbidimetric), Lipase	CET	Class 1	Clinical Chemistry	No	2008-05-30
Calibrators, Drug Mixture	DKB	Class 2	Clinical Toxicology	No	2008-05-30
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	Class 1	Clinical Chemistry	No	2008-05-30
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)	MOJ	Class 2	Clinical Toxicology	No	2008-05-30
Drug Mixture Control Materials	DIF	Class 1	Clinical Toxicology	No	2008-05-30
Calibrators, Drug Specific	DLJ	Class 2	Clinical Toxicology	No	2008-05-30
Fluorescence Polarization Immunoassay, Phenobarbital	LGQ	Class 2	Clinical Toxicology	No	2008-05-30
Calibrator, Multi-Analyte Mixture	JIX	Class 2	Clinical Chemistry	No	2008-05-30
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	Class 2	Clinical Chemistry	No	2008-05-30
Radioassay, Triiodothyronine Uptake	KHQ	Class 2	Clinical Chemistry	No	2008-05-30
Nephelometer	JZW	Class 1	Immunology	No	2008-05-30
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	Class 2	Clinical Toxicology	No	2008-05-30
System, Test, Urinary Methylmalonic Acid	LPT	Class 2	Clinical Chemistry	No	2008-05-30
Biuret (Colorimetric), Total Protein	CEK	Class 2	Clinical Chemistry	No	2008-05-30
Igg, Antigen, Antiserum, Control	DEW	Class 2	Immunology	No	2008-05-30
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	Class 1	Clinical Chemistry	No	2008-05-30
Drug Specific Control Materials	LAS	Class 1	Clinical Toxicology	No	2008-05-30
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	Class 2	Immunology	No	2008-05-30
Clinical Sample Concentrator	JJH	Class 1	Clinical Chemistry	No	2012-05-17

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 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 Elecsys 2010 cobas E 2010 cobas e411 Analyzer cobas Elecsys 2010 Analyzer EVO ADDITIONAL E MODULE cobas e 411 SW version 02-08 Install CD

Establishment Types

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

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Owner / Operator

Roche Diagnostics Operations Inc.

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Product Codes

Find other entries with 109 product codes: JIT, JJY, JJX, CGN, PPM, LCP, JIF, DIH, DFC, JZG, LAN, CJX, KNK, CIT, KXS, CZP, DAD, DCF, DCN, DKJ, CIC, DAO, LDP, DIO, DDG, DJG, CHN, CGZ, LCM, CJE, KHS, LEG, NDW, CIX, LBS, LDJ, JHS, JFJ, KLB, LBZ, CDQ, NDY, CEO, DHR, DLZ, DIS, DJR, GHH, JIY, DLB, DBF, JXM, OAV, JGQ, KXT, CDT, CFJ, LEH, DEM, CGX, JJE, CHH, JGJ, DKZ, KLP, DIP, KHP, JGS, DER, CZW, MRR, JMO, CIG, CJW, DBI, JXN, KLS, NQD, CEM, CFR, DDR, LAR, DML, OWD, NJT, LGS, DEL, LGI, JXO, JHN, CET, DKB, CKA, MOJ, DIF, DLJ, LGQ, JIX, KLI, KHQ, JZW, DIC, LPT, CEK, DEW, JQB, LAS, CFN, JJH

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