LDL testing kit - India CDSCO Medical Device Registration

LDL testing kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000049_a379673de65e033baf271658f95adc1e_4e7c0100c90ff6dc907b4dca46b260f6. This device is marketed under the brand name PROLISA T4 ELISA. The license holder is Promea Therapeutics Private Limited, and it is classified as Device Class Class B. The approving authority is Telangana.

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CDSCO Registered

Class Class B

LDL testing kit

UID: MFG/IVD/2021/000049_a379673de65e033baf271658f95adc1e_4e7c0100c90ff6dc907b4dca46b260f6

Brand Name

PROLISA T4 ELISA

License Holder

Promea Therapeutics Private Limited

Device Class

Class B

Approving Authority

Telangana

Product Information

The intended use of the kit is to determine the concentration of low-density lipoprotein levels in human serum or plasma

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