Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
VEUPLEX™ TBI assay
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08809901510067
- Basic UDI-DI Code
- B-08809901510067
- Reference
- EZ-TBIV
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- EzDiaTech, Inc.
Additional Description
VEUPLEX™ TBI assay is intended to be used for quantitative detection of multiple biochemical markers named GFAP (Glial fibrillary acidic protein, hereinafter GFAP) and UCHL1 (Ubiquitin carboxyl-terminal hydrolase L1, hereinafter UCHL1) in a serum of patients suspected of traumatic brain injury(intracranial injury) and a semiquantitative interpretation of test results, using fluorescence immunoassay method in order to monitor the patients before/without a neuroimaging radiological scan following head injury. This product is for professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102019099 | SPECIFIC PROTEINS - OTHER |
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