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/2019/000157_b882ced448184128d193b6ffa1fcce0f_6971ad3e50e0293b3dc161effd58d493. 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

STROMATOLYSER-WH

UID: IMP/IVD/2019/000157_b882ced448184128d193b6ffa1fcce0f_6971ad3e50e0293b3dc161effd58d493

Brand Name

UFII PACK-SED

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

STROMATOLYSER WH is a reagent that lyses RBC for accurate WBC count determination WBC trimodal 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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STROMATOLYSER-WH

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

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