Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
MONOGENETIC DISORDERS TESTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975358885101
- Basic UDI-DI Code
- B-06975358885101
- Reference
- 04110003
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biofast Biotechnology Co., Ltd.
Additional Description
The kit is an in vitro diagnostic devices for the detection of copy number changes of exons 7 and 8 in SMN1 and SMN2 gene. This test can be amplified with human genomic DNA purified from whole blood by multiplex Polymerase Chain Reaction and followed by capillary electrophoresis platform to determine the copy numbers of both SMN1 and SMN2 .
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010199 | MONOGENETIC DISORDERS TESTS - OTHER |
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