Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
BioGerm SARS-CoV-2 Antigen Self Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06974677690366
- Basic UDI-DI Code
- B-06974677690366
- Reference
- ZC-MY-001-01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
Additional Description
BioGerm SARS-CoV-2 Antigen Self Test is intended for the qualitative determination of SARS-CoV-2 antigen in human anterior nasal swab. More exactly, it is intended for detection of nucleocapsid protein of SARS-CoV-2 from individuals to aid in the diagnosis of SARS-CoV-2 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090399 | RETROVIRUSES - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-076/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).
CERA-CHEK™ Lactate Measuring System
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
CERA-CHEK™ Lactate Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
BGI
Device
EU IVDD
·
Eu Ivd Self Testing
·BGI EUROPE A/S·On the market
Lactate Pro 2 (LT-1730)
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market