FDA Registration
Active
🇨🇭 Switzerland
MICRO ELECTRODE CA++
Reg #: 3003795116
·
FEI: 3003795116
·
Expires 2025
Products
12
Proprietary Names
17
Establishment Types
1
Classifications
12
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
- K032311
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 |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2010-02-16 |
| Whole Blood Hemoglobin Determination | KHG | Class 2 | Hematology | No | 2010-02-16 |
| Oxyhemoglobin | GGZ | Class 2 | Hematology | No | 2010-02-16 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2010-02-16 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2010-02-16 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2010-02-16 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2010-02-16 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2010-02-16 |
| Acid Hematin | GGF | Class 2 | Hematology | No | 2010-02-16 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2010-02-16 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2010-02-16 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2010-02-16 |
Proprietary Names
MICRO ELECTRODE CA++
MICRO ELECTRODE PO2 AVL
cobas b 221<4>=Roche OMNI S4 system
MSS CASSETTE GLU
AUTO QC MODUL cobas b 221=Roche OMNI S
MICRO ELECTRODE NA+
MSS CASSETTE GLU/LAC/UREA
cobas b 221<6>=Roche OMNI S6 system
MICRO ELECTRODE CL
MICRO ELECTRODE PH AVL
MICRO ELECTRODE K+
MSS CASSETTE GLU/LAC
MICRO ELECTRODE PCO2 AVL
cobas b 221<2>=Roche OMNI S2 system
cobas b 221 <2> Roche OMNI S2 system
MICRO ELECTRODE REF
cobas b 221 <6> Roche OMNI S6 system
Establishment Types
Manufacture Medical Device