ABX Alphalyse (ABX Alphalyse ) - India CDSCO Medical Device Registration

ABX Alphalyse (ABX Alphalyse ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000062_8db7ff86e6ad5cbd6f0a5cbc89b16320_a8600f0fab0974a954c5edf939866d8c. This device is marketed under the brand name Yumizen. The license holder is HORIBA INDIA Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

ABX Alphalyse (ABX Alphalyse )

UID: IMP/MD/2018/000062_8db7ff86e6ad5cbd6f0a5cbc89b16320_a8600f0fab0974a954c5edf939866d8c

Brand Name

Yumizen

License Holder

HORIBA INDIA Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

"ABX Alphalyse is lysing solution intended for in vitro diagnostic use and designed for lysing erythrocytes (Yumizen) and for hemoglobin determination on HORIBA Medical blood cell counters "

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ABX Alphalyse (ABX Alphalyse ) - India CDSCO Medical Device Registration

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Approving Authority

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