Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Strep A Rapid Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895474252
- Basic UDI-DI Code
- B-06970895474252
- Reference
- R226T020B0C0
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
The Strep A Antigen Test Kit is a rapid chromatographic immunoassay for the qualitative detection of Strep A (Group A Streptococcus) antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcus infection. This test is intended for use as an aid in the differential diagnosis of Group A Streptococcus infections in humans in conjunction with clinical and epidemiological risk factors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090103 | STREP. A - RT & POC |
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