Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05210166000010
- Basic UDI-DI Code
- B-05210166000010
- Reference
- 000055
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- BIOPIX DNA TECHNOLOGY P.C.
Additional Description
The COV19 qcLAMP kit is a Nucleic Acid Amplification Test (NAAT) kit based on the real-time colorimetric LAMP method (qcLAMP) for the detection of SARS-CoV-2 N-gene RNA target. The COV19 qcLAMP kit does not require RNA extraction and can be used directly with nasopharyngeal and oropharyngeal swab specimens. Alternatively, the kit can also be used with extracted RNA.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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