CERA-CHEK™ Hb Plus Hemoglobin Measuring System
Basic Information
- Primary DI
- 08800065152018
- Basic UDI-DI Code
- B-08800065152018
- Reference
- B400M10
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The CERA-CHEK™ Hb Plus Hemoglobin Measuring System comprising the hemoglobin meter, the compatible test strips, and control solutions, is an automated system intended for the quantitative measurement of hemoglobin levels in venous blood and fresh capillary whole blood drawn the fingertip. The system is intended to be used for self-testing by lay persons who need to checkup the hemoglobin level or with anemia (especially iron deficiency anemia) and for near-patient testing by healthcare professionals to monitor the effectiveness of hemoglobin level control. The CERA-CHEK™ Hb Plus Hemoglobin Measuring System should not be used for the diagnosis of or screening for anemia. The system is intended for in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V74 091763 0019 | TÜV SÜD Product Service GmbH | Expired |
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