Direct Bilirubin/Total Protein/Alkaline Phosphatase/ Gamma Glutamyl Transferase Reagent Kit
- UID
- IMP/IVD/2020/001094_b3e1acd3ab8eb78c6e24ccbac3a76479_c07e9ee65af9ee25f0ca347b10dcb52c
- Device class
- Class B
- Brand name
- capillary
- License holder
- PTS Diagnostics India Private Limited
- Approving authority
- CDSCO
- Product information
- The Direct Bilirubin/Total Protein/Alkaline Phosphatase/Glutamyl Transferase Reagent Kit is intended to quantitatively determine the concentration of direct bilirubin (capillary), total protein (capillary) and activity of alkaline phosphatase (capillary), γ-glutamyl transferase (capillary) 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.
Direct Bilirubin/Total Protein/Alkaline Phosphatase/ Gamma Glutamyl Transferase Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001094_b3e1acd3ab8eb78c6e24ccbac3a76479_c07e9ee65af9ee25f0ca347b10dcb52c. This device is marketed under the brand name capillary. The license holder is PTS Diagnostics India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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