LH Lyse - India CDSCO Medical Device Registration

LH Lyse is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000345_819c0fadaa2a01844f48d85223bc6cd0_cacec0b1a4f0360b359063c3c254af56. This device is marketed under the brand name KT05 DIL. The license holder is Operon Biotech & Healthcare, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

LH Lyse

UID: IMP/IVD/2021/000345_819c0fadaa2a01844f48d85223bc6cd0_cacec0b1a4f0360b359063c3c254af56

Brand Name

KT05 DIL

License Holder

Operon Biotech & Healthcare

Device Class

Class B

Approving Authority

CDSCO

Product Information

This product is used to dissolve RBC and maintain the morphology of the cells needed to be analyzed before blood cell analysis thereby facilitates cell sorting or HGB quantification