Direct Bilirubin/Total Protein/Alkaline Phosphatase/ Gamma Glutamyl Transferase Reagent Kit - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Direct Bilirubin/Total Protein/Alkaline Phosphatase/ Gamma Glutamyl Transferase Reagent Kit

UID: IMP/IVD/2020/001094_b3e1acd3ab8eb78c6e24ccbac3a76479_c07e9ee65af9ee25f0ca347b10dcb52c

Brand Name

capillary

License Holder

PTS Diagnostics India Private Limited

Device Class

Class B

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.

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Brand: capillary

PTS Diagnostics India Private Limited

Direct Bilirubin/Total Protein/Alkaline Phosphatase/ Gamma Glutamyl Transferase Reagent Kit - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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