ELite H580 Lyse3 - India CDSCO Medical Device Registration

ELite H580 Lyse3 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000132_bb76af0db43ad966be2279c9622fd52c_0389151983b04088c8063535df4511d3. This device is marketed under the brand name FERRITIN CONTROL HIGH. The license holder is M/s.Transasia Bio-Medicals Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

ELite H580 Lyse3

UID: IMP/IVD/2019/000132_bb76af0db43ad966be2279c9622fd52c_0389151983b04088c8063535df4511d3

Brand Name

FERRITIN CONTROL HIGH

License Holder

M/s.Transasia Bio-Medicals Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

ELite H580 Lyse3 is used for differentiation of white blood cells on hematology analysers ELite 580

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