Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇨🇦 Canada
Multiplo Rapid TP/HIV Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-8153110050085Y
- Basic UDI-DI Code
- B-8153110050085Y
- Reference
- 815311005008
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- MedMira Laboratories Inc.
Additional Description
Qualitative immunoassay for the detection of antibodies to human immunodeficiency virus Type 1 and 2 (anti-HIV-1/2) and/or to Treponema pallidum bacteria, the causative agent of syphilis in human serum and plasma.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0204 | INFECTIOUS IMMUNOLOGY INSTRUMENTS |
| W0105900201 | BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2005 12 0495 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | Expired |
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