Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
FRAGILE X SYNDROME
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975358885002
- Basic UDI-DI Code
- B-06975358885002
- Reference
- 04110001
- 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 to detect the CGG reapeat region in the 5'- untanslated region of the fragile X mental retardation 1 (FMR1) gene. 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 numbers of CGG repeats.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010104 | FRAGILE X SYNDROME |
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