OnSite HIV 1/2 Ab Plus Combo Rapid Test
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Basic Information
- Primary DI
- 00855402007771
- Basic UDI-DI Code
- B-00855402007771
- Reference
- R0011C
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- CTK Biotech Inc.
Additional Description
The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection of anti-HIV-1 (including subtype O) and anti-HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with HIV. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of healthcare providers. Alternative test method(s) should be used to confirm the test result obtained by this device.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090302 | HIV 1 / 2 - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.2020-IVD/QS-008 | 3EC International a.s. | Expired |
Available In Countries
Similar Devices
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