Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
AUTODXTM U-Albumin Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800031900353
- Basic UDI-DI Code
- B-08800031900353
- Reference
- E1C800
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- DxGen Corp.
Additional Description
AUTODXTM U-Albumin Test is an in vitro diagnostic (IVD) test for the quantitative measurement of low albumin concentrations in human urine.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160101 | ALBUMIN INCL. UALBUMIN RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 002533 0006 | TÜV SÜD Product Service GmbH |
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