Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
π¨π³ China
HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06952804810726
- Basic UDI-DI Code
- B-06952804810726
- Reference
- HIV-W23
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
Additional Description
The HIV Rapid Test Device (HIV1/2) is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HIV 1/HIV-2 in human serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of HIV infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090302 | HIV 1 / 2 - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | CeCert/077/W/E.1 | CeCert Sp. z o.o. | Expired |
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