Eu Ivdd
Eu Ivd Self Testing
On The Market
🇺🇸 United States
Fortel® Kidney Disease (Microalbumin) Screening Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00083059140019
- Basic UDI-DI Code
- B-00083059140019
- Reference
- 1400-1
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Biomerica, Inc.
Additional Description
Rapid lateral flow test intended for in vitro diagnostic use for the qualitative detection of elevated levels of human albumin in urine.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160101 | ALBUMIN INCL. UALBUMIN RT & POC |
Certificates
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