Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
SARS-CoV-2 Antigen Test Cassette
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06970895474146
- Basic UDI-DI Code
- B-06970895474146
- Reference
- R220T02PB0C0
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
The SARS-CoV-2 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens in nasal swab samples from human. The test is intended to an aid in the rapid diagnosis of SARS-CoV-2 infection. Device is for self-testing use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040618 | BOCAVIRUS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-010/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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