STROMATOLYSER-WH - India CDSCO Medical Device Registration

STROMATOLYSER-WH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000255_b882ced448184128d193b6ffa1fcce0f_9335415119c4a05491a208c0e06ae821. This device is marketed under the brand name UXII PACK-SED. The license holder is Sysmex India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

STROMATOLYSER-WH

UID: IMP/IVD/2019/000255_b882ced448184128d193b6ffa1fcce0f_9335415119c4a05491a208c0e06ae821

Brand Name

UXII PACK-SED

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

STROMATOLYSER-WH is a reagent that lyses RBC for accurate WBC count determination, WBC tri-modal size distribution analysis and hemoglobin level measurement. The reagent is colorless transparent and contains no cyanide or azide compound. It is intended for use in conjunction with selected Sysmex Automated Hematology Analyzer

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CA CLEAN I

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

STROMATOLYSER-WH - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CA CLEAN I

CELLSHEATH

CELLPACK DCL

UXII SEARCH-SED

Wash Solution No. 9

SULFOLYSER

CELLPACK

UFII SEARCH-BAC

STROMATOLYSER-NR

LYSERCELL WPC

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner