Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
๐ฆ๐บ Australia
Simplitude ByMe
Devices (same UDI-DI)
1
Certificates
2
Countries
7
Notified Bodies
2
Basic Information
- Primary DI
- 09349609000600
- Basic UDI-DI Code
- B-09349609000600
- Reference
- P003948A1-10
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Atomo Diagnostics Limited
Additional Description
The Simplitude ByMe HIV Self Test is a single-use, immunochromatographic, rapid in-vitro diagnostic test for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV 2) in whole blood. The HIV Self Test is intended to be used by untrained lay users as a self-test to aid in the diagnosis of infection with HIV-1 and HIV-2 from samples of fresh, whole blood obtained through a finger stick blood collection technique. The device requires a sample size of 10 ยตL.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105030402 | HIV MULTIPLE ANTIBODY |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | 716015 | BSI Group The Netherlands B.V. | Expired |
| IVDD Annex IV (excluding sections 4, 6) | 637070 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ซ๐ฎ Finland
๐ณ๐ด Norway
๐ธ๐ช Sweden
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