CELLPACK DCL - India CDSCO Medical Device Registration

CELLPACK DCL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000157_f4f3f759ae357a4442a2bda9a7d735bd_c49d18d1402709917c0c22edd25d707c. This device is marketed under the brand name UFII PACK-SED. The license holder is Sysmex 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

CELLPACK DCL

UID: IMP/IVD/2019/000157_f4f3f759ae357a4442a2bda9a7d735bd_c49d18d1402709917c0c22edd25d707c

Brand Name

UFII PACK-SED

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only CELLPACK DCL is a reagent for measuring the numbers and sizes of RBC and platelets by the Hydrodynamically focussed DC detection method. With the addition of the specified lyse reagent for hemoglobin concentration determination, it can also be used to analyze hemoglobin concentration. Also it can be used as a sheath fluid for FCM detector. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex

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CELLPACK DCL

Brand: Stromatolyser - WH

Sysmex India Private Limited

CELLPACK DCL - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CELLPACK DCL

CELLPACK DCL

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