FDA Registration
Active
🇩🇪 Germany
H ISE REFERENCE ELECTRODE
Reg #: 9610126
·
FEI: 3002806559
·
Expires 2025
Products
9
Proprietary Names
16
Establishment Types
4
Classifications
9
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
- K060373
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 |
|---|---|---|---|---|---|
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2008-05-30 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2008-05-30 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2008-05-30 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2008-05-30 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2008-05-30 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2008-05-30 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2008-05-30 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2008-05-30 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2008-05-30 |
Proprietary Names
H ISE REFERENCE ELECTRODE
REFERENCE ELECTRODE
REFERENCE ELECTROLYTE (1x250 ML)
cobas INTEGRA ISE REFERENCE SOL 250ML
ISE Reference Electrolyte 300ML
COBAS INTEGRA OPIATES 300/2000 200T
System SW Install CD cobas 311 LCP3
cobas 4000 c311
c311
cobas c 311 Internat. CD version 01-11
SW COBAS 6000 INSTALL CD V06-03
cobas 6000
Tina-quant Complement C3c Ver.2
C3C-2, 150T, cobas c 503
cobas c 311 Install SW version 01-12
cobas c 311 Lang-Pack_SW01-12_English
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device