MULTIPLE PARAMETER BLOOD TEST
Basic Information
- Primary DI
- D-02B0013YJ
- Basic UDI-DI Code
- B-02B0013YJ
- Reference
- 1G001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Direct Bilirubin/Total Protein/Alkaline Phosphatase/Glutamyl Transferase Reagent Kit is intended to quantitatively determine the concentration of direct bilirubin (DB), total protein (TP) and activity of alkaline phosphatase (ALP), γ-glutamyl transferase (GGT) in human serum. Clinically, it is mainly used for auxiliary diagnosis of liver diseases. DB, also known as conjugated bilirubin, is produced when indirect bilirubin goes into liver and combines with glucuronic acid under the effect of glucuronyl transferase. Elevated DB indicates that there are difficulties for bilirubin to be excreted through biliary tract after going out of liver. Clinically, elevated TP and decreased TP are both significant. Plasma concentration due to loss of water, or increased production of serum protein, can cause the concentration of total protein to elevate; the decrease of total protein can be caused by: plasma dilution due to increase of water, malnutrition or increased consumption, less production due to liver damage, or the loss of large quantities of plasma protein. ALP exists in a variety of human tissues all over the human body. The measuring of ALP is mainly used for the diagnosis and monitoring of liver diseases, gall diseases and bone-related diseases. The GGT in serum mainly comes from liver. It is a sensitive indicator of liver disease, as high GGT is observed in liver diseases of various causes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060109 | MULTIPLE PARAMETER BLOOD TEST |
| W01010230 | TOTAL PROTEIN |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).