cobas 8000 cobas ISE MODULE [DOUBLE]

Reg #: 3003795116 · FEI: 3003795116 · Expires 2025

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: ROCHE DIAGNOSTICS INTERNATIONAL LTD.
Registration Number: 3003795116
FEI Number: 3003795116
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: FORRENSTRASSE 2
City: ROTKREUZ Zug
Country: CH

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

cobas 8000 cobas ISE MODULE [DOUBLE] cobas 8000 CORE UNIT Tina-quant IgA Gen.2 cobas 8000 C 502 MODULE ISE Indirect Na, K, Cl for Gen.2 cobas 8000 cobas C 701 MODULE cobas 8000 c702 MODULE cobas 8000 e 602 MODULE SCISE Self-Contained ISE Support Box cobas 8000 Core cobas e602 Analyzer cobas 8000 Data Manager cobas c502 Analyzer ISE Compensator cobas 8000 ISE Module cobas c702 Analyzer cobas c701 Analyzer SW Install CD c8000 V06-05 COBAS 8000 C 502 MODULE CU SW DM c8000 V165 cobas 8000 CORE UNIT CU cobas 8000 system software cobas 8000 data manager SW c8000 data manager 168 cobas 8000 Modular Analyzer Series SW WIN10 (2015) MIGRAT. KIT C8000 RP5810

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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