AMMONIA
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Basic Information
- Primary DI
- 16970301471018
- Basic UDI-DI Code
- B-16970301471018
- Reference
- EGSAMM
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Beijing Strong Biotechnologies, Inc.
Additional Description
INTENDED USE：For in vitro quantitative determination of ammonia in plasma. CLINICAL SIGNIFICANCE：Under normal circumstances, ammonia converts to urea in the liver. With severe liver disease, ammonia cannot be converted and eliminated from the circulation, which in turn causes blood ammonia increase. High blood ammonia is neurotoxic, and will lead hepatic encephalopathy (hepatic coma). Adult plasma ammonia determination mainly use for monitoring and treatment of hepatic coma.In addition, plasma ammonia determination can be used in pediatric diagnosis of Reye's syndrome.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010301 | AMMONIA |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CIBG-20222721 | TÜV Rheinland LGA Products GmbH |
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