cobas 8000 cobas ISE MODULE [DOUBLE]

Reg #: 9610529 · FEI: 3002806560 · Expires 2025

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: ROCHE DIAGNOSTICS GMBH
Registration Number: 9610529
FEI Number: 3002806560
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: NONNENWALD 2
City: PENZBERG Bavaria
Country: DE

Regulatory Submissions

510(k) Number: K100853

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
Enzyme Immunoassay, N-Acetylprocainamide	LAN	Class 2	Clinical Toxicology	No	2010-09-15
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	Class 2	Immunology	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
System, Test, Beta-2-Microglobulin Immunological	JZG	Class 2	Immunology	No	2010-09-15
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2010-09-15
Enzymatic Method, Ammonia	JIF	Class 1	Clinical Chemistry	No	2010-09-15
Assay, Glycosylated Hemoglobin	LCP	Class 2	Hematology	No	2010-09-15
Acid, Uric, Uricase (Colorimetric)	KNK	Class 1	Clinical Chemistry	No	2010-09-15
Acid Phosphatase, Disodium Phenylphosphate	CJX	Class 2	Clinical Chemistry	No	2010-09-15
Colorimetry, Cholinesterase	DIH	Class 1	Clinical Toxicology	No	2010-09-15
Haptoglobin, Antigen, Antiserum, Control	DAD	Class 2	Immunology	No	2010-09-15
Transferrin, Antigen, Antiserum, Control	DDG	Class 2	Immunology	No	2010-09-15
Colorimetry, Acetaminophen	LDP	Class 2	Clinical Toxicology	No	2010-09-15
Igm (Mu Chain Specific), Antigen, Antiserum, Control	DAO	Class 2	Immunology	No	2010-09-15
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2010-09-15
Colorimetry, Salicylate	DKJ	Class 2	Clinical Toxicology	No	2010-09-15
Albumin, Antigen, Antiserum, Control	DCF	Class 2	Immunology	No	2010-09-15
Immunochemical, Ceruloplasmin	CHN	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Opiates	DJG	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2010-09-15
Cresolphthalein Complexone, Calcium	CIC	Class 2	Clinical Chemistry	No	2010-09-15
System, Test, C-Reactive Protein	DCN	Class 2	Immunology	No	2010-09-15
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2010-09-15
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	Class 2	Clinical Chemistry	No	2010-09-15
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	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
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2010-09-15
Enzymatic, Carbon-Dioxide	KHS	Class 2	Clinical Chemistry	No	2010-09-15
Bromcresol Green Dye-Binding, Albumin	CIX	Class 2	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Quinidine	LBZ	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Valproic Acid	LEG	Class 2	Clinical Toxicology	No	2010-09-15
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	Class 1	Clinical Chemistry	No	2010-09-15
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	Class 2	Clinical Chemistry	No	2010-09-15
Assay, Porphyrin, Spectrophotometry, Lithium	NDW	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	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
Ferritin, Antigen, Antiserum, Control	DBF	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Diphenylhydantoin	DIP	Class 2	Clinical Toxicology	No	2010-09-15
Fibrin Split Products	GHH	Class 2	Hematology	No	2010-09-15
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2010-09-15
Radioimmunoassay, Vancomycin	LEH	Class 2	Clinical Toxicology	No	2010-09-15
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2010-09-15
Radioimmunoassay, Lsd (125-I)	DLB	Class 2	Clinical Toxicology	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
Amikacin Serum Assay	KLP	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2010-09-15
Turbidimetric, Total Protein	JGQ	Class 2	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2010-09-15
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2010-09-15
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Digoxin	KXT	Class 2	Clinical Toxicology	No	2010-09-15
Mycophenolic Acid Test System	OAV	Class 2	Clinical Toxicology	No	2010-09-15
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2010-09-15
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	Class 2	Clinical Chemistry	No	2010-09-15
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	Class 1	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Phenobarbital	DLZ	Class 2	Clinical Toxicology	No	2010-09-15
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	Class 2	Immunology	No	2010-09-15
Alpha-1-Lipoprotein, Antigen, Antiserum, Control	DER	Class 2	Immunology	No	2010-09-15
System, Test, Low Density, Lipoprotein	MRR	Class 1	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2010-09-15
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	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
Complement C3, Antigen, Antiserum, Control	CZW	Class 2	Immunology	No	2010-09-15
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2010-09-15
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method	DML	Class 2	Clinical Toxicology	No	2010-09-15
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	Class 2	Immunology	No	2010-09-15
Enzyme Immunoassay, Procainamide	LAR	Class 2	Clinical Toxicology	No	2010-09-15
Bromcresol Purple Dye-Binding, Albumin	CJW	Class 2	Clinical Chemistry	No	2010-09-15
Enzyme Immunoassay, Theophylline	KLS	Class 2	Clinical Toxicology	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
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2010-09-15
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2010-09-15

Proprietary Names

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Establishment Types

Manufacture Medical Device

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Owner / Operator

Roche Diagnostics Operations Inc.

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Product Codes

Find other entries with 78 product codes: LAN, DFC, KXS, CZP, JZG, CIT, JIF, LCP, KNK, CJX, DIH, DAD, DDG, LDP, DAO, CGZ, DKJ, DCF, CHN, DJG, DIO, CIC, DCN, CHH, CJE, CEO, CDQ, NDY, LCM, KHS, CIX, LBZ, LEG, LBS, JHS, NDW, LDJ, JFJ, KLB, DBF, DIP, GHH, CIG, LEH, DHR, DLB, CGX, JJE, KLP, DKZ, JGQ, DJR, JXM, JIY, KXT, OAV, JGJ, CFJ, CDT, DLZ, DEM, DER, MRR, DIS, JMO, KHP, JGS, CZW, CFR, DML, NQD, LAR, CJW, KLS, DBI, JXN, DDR, CEM

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