Eu Ivdd
Eu Ivd General
On The Market
🇹🇼 Taiwan
VitaPCR Strep A
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719878570091
- Basic UDI-DI Code
- B-04719878570091
- Reference
- PCRAE0107
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Additional Description
The VitaPCR™ Strep A Assay performed on the VitaPCR™ Instrument is a rapid molecular in vitro diagnostic test utilizing a real-time polymerase chain reaction (PCR) amplification technology for the qualitative detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in oropharyngeal (OP) or throat swab specimens from patients with signs and symptoms of pharyngitis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011103 | STREP. A DETECTION BY NA REAGENTS |
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