Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
REDI-Dx
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00850521006032
- Basic UDI-DI Code
- B-00850521006032
- Reference
- 135488
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- DxTerity Diagnostics Inc.
Additional Description
The REDI-Dx Test is a sequence specific chemical ligation (DxDirect®) and polymerase chain reaction (PCR) based in vitro diagnostic biodosimetry test for the quantitative detection of mRNA in whole human blood samples by capillary electrophoresis (CE) on the Applied Biosystems® (ABI) 3500xL Dx Genetic Analyzer. The mRNA results are further used to calculate, and report absorbed radiation dose estimates.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102019099 | SPECIFIC PROTEINS - OTHER |
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