Eu Ivdr
Eu Ivd Class A
On The Market
🇱🇰 Sri Lanka
Bactfast
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04793002939008
- Basic UDI-DI Code
- 4793002939BactfastDZ
- Reference
- CGNBF001.100
- Device Types
-
New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Credence Genomics Pvt. Ltd.
Additional Description
The Bactfast® Assay for ONT Sequencing is an in vitro diagnostic test, intended for the identification and classification of 22,000 bacterial organisms at the genus and species level, in human clinical samples. The test is manual and is intended for use by trained professionals only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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