THE EDGE
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Basic Information
- Primary DI
- D-47136487610A05K
- Basic UDI-DI Code
- B-47136487610A05K
- Reference
- S54108, S54153, S54154, S54155, S54156, S54157, S54158
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
THE EDGE Blood Lactate Monitoring System provides you with important information concerning individual metabolism and oxygen debt. The system is especially designed for applications in a number of disorders including: liver disease, heart disease, diabetes mellitus, muscular dystrophy, thiamine deficiency, neoplastic disorders. Moreover, it can also be implemented in the field of medical diagnostics by specialists. Due to its reliable and accurate result evaluation (in-vitro), it is suitable for use in the support of the decision for further medical treatment of the patient. THE EDGE Blood Lactate Monitoring System is designed for both personal use and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
| W0101060104 | LACTATE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
Available In Countries
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