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DIRECT HDL-CHOLESTEROL DIAGNOSTIC KIT - India CDSCO Medical Device Registration

DIRECT HDL-CHOLESTEROL DIAGNOSTIC KIT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000144_9720f48ae26c8eea22b52b30dec75c40_a833e35ff788a19628f77d7ed0500d9e. This device is marketed under the brand name LDH โ€“ DGKC. The license holder is Randox Laboratories (India) Pvt.Ltd, and it is classified as Device Class Class B. The approving authority is Karnataka.

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CDSCO Registered
Class Class B
DIRECT HDL-CHOLESTEROL DIAGNOSTIC KIT
UID: MFG/IVD/2022/000144_9720f48ae26c8eea22b52b30dec75c40_a833e35ff788a19628f77d7ed0500d9e

Brand Name

LDH โ€“ DGKC

Device Class

Class B

Approving Authority

Karnataka

Product Information

The Direct HDL-Cholesterol (LDH โ€“ DGKC) device is intended, Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma. This product is suitable for use on semi-automated instruments

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