FDA Registration
Active
🇩🇪 Germany
COBAS INTEGRA REAGENT CASSETTES
Reg #: 9610126
·
FEI: 3002806559
·
Expires 2025
Products
13
Proprietary Names
26
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- ROCHE DIAGNOSTICS GMBH
- Registration Number
- 9610126
- FEI Number
- 3002806559
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SANDHOFER STRASSE 116
- City
- MANNHEIM Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K972250
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 protected]
- Phone
- 317 5214603
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Lsd (125-I) | DLB | Class 2 | Clinical Toxicology | No | 2008-06-06 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2008-06-06 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2008-06-06 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2008-06-06 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2008-06-06 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2008-06-06 |
| Olive Oil Emulsion (Turbidimetric), Lipase | CET | Class 1 | Clinical Chemistry | No | 2008-06-06 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2008-06-06 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2008-06-06 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2008-06-06 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2008-06-06 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2008-06-06 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2008-06-06 |
Proprietary Names
COBAS INTEGRA REAGENT CASSETTES
GGT HICO 200T cobas c111
AMYL Gen.2, 300Tests, cobas c, Integra
UREAL, 500Tests, cobas c, Integra
NH3L 100T cobas c 111
GGT Gen.2, 1200Tests, cobas c701
cobas c 70X GGT/1200
NH3L, 150Tests, cobas c, Integra
AMYL Gen.2, 750Tests cobas c701
GGT Gen.2, 400Tests, cobas c, Integra
Lipase color 100T c111
cobas INTEGRA AMMONIA 150
cobas c 70X Urea Nitrogen/500
UREA 400T cobas c 111
cobas C INTEGRA UREAL
a-Amylase 200T cobas c 111
UREAL, 1900Tests, cobas c701
COBAS INTEGRA LSD 200
Ammonia
ONLINE DAT Lysergic Acid Diethylamide
AMY-P, 450T, cobas c 503
?-Amylase EPS ver.2
Urea/BUN
LSD, 200Test, c503
AMYL2, 750T, cobas c 503
UREAL, 600Tests, cobas c503
Establishment Types
Manufacture Medical Device