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Basic Information
- Primary DI
- D-02B0020YF
- Basic UDI-DI Code
- B-02B0020YF
- Reference
- 2P001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
Homocysteine (HCY) Reagent Kit is intended to quantitatively determine concentration of HCY in human serum in vitro. Clinically, it is mainly used for the auxiliary diagnosis of hyperhomocysteinemia and atherosclerosis and the risk evaluation for cardiovascular disease. Homocysteine is one of the independent risk factors of stroke, coronary atherosclerosis and myocardial infarction, whose concentration is directly proportional to the risk of disease. Meanwhile, its concentration also serves as a sensitive index of vitamin B12 and folate deficiency in accordance with the metabolic characteristics of homocysteine.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021307 | HOMOCYSTEINE |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).