Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇨🇳 China
HBsAg Rapid Test Cassette
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06936983122955
- Basic UDI-DI Code
- B-06936983122955
- Reference
- IHBSG-402
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The HBsAg Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in human whole blood, serum or plasma to aid in the diagnosis of HBsAg infection. The product is intended to be used by trained laboratory personnel. For laboratory use only. The test provides preliminary test results. Negative results will not preclude Hepatitis B virus infection and they can’t be used as the sole basis for treatment or other management decision. Not for Self-testing use. Not for near-patient use. Not for blood donor screening.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090201 | HBSAG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CeCert/102/W/E.1 | CeCert Sp. z o.o. | Expired |
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