Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
DUCHENNE MUSCULAR DYSTROPHY
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975358885217
- Basic UDI-DI Code
- B-06975358885217
- Reference
- 04110006
- 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 exon deletion or duplications in human DMD gene as a cause for Duchenne muscular dystrophy and Becker muscular dystrophy. This assay 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 the 79 exons in the DMD gene .
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010102 | DUCHENNE MUSCULAR DYSTROPHY |
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