Bilirubin Direct - India CDSCO Medical Device Registration

Bilirubin Direct is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000144_ee25ceeb0768c6b0cd1501c2ab6dcc2c_fe4ff9c6094e02a5dd65269024d69488. This device is marketed under the brand name LDH – 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

Bilirubin Direct

UID: MFG/IVD/2022/000144_ee25ceeb0768c6b0cd1501c2ab6dcc2c_fe4ff9c6094e02a5dd65269024d69488

Brand Name

LDH – DGKC

License Holder

Randox Laboratories (India) Pvt.Ltd

Device Class

Class B

Approving Authority

Karnataka

Product Information

The Bilirubin Direct (LDH – DGKC) System Pack is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. This product is suitable for automated use and on a variety of open non-dedicated chemistry instruments

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Glucose Diagnostic Kit

Brand: LDH – DGKC

Randox Laboratories (India) Pvt.Ltd

Bilirubin Direct - India CDSCO Medical Device Registration

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License Holder

Device Class

Approving Authority

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