SULFOLYSER - India CDSCO Medical Device Registration

SULFOLYSER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000157_ec46ea1610307ed7e0954ddef889bc09_d14203074ac459252a3e5ff90b0e410f. 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

SULFOLYSER

UID: IMP/IVD/2019/000157_ec46ea1610307ed7e0954ddef889bc09_d14203074ac459252a3e5ff90b0e410f

Brand Name

UFII PACK-SED

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers,pocH-pack L(UFII PACK-SED)(pocH-pack L(UFII PACK-SED))-Sysmex pocH pack L (UFII PACK-SED) 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 pocH-100i Automated Hematology Analyzer.,pocH-Pack D(UFII PACK-SED)(pocH-Pack D(UFII PACK-SED))-Diluent Sysmex pocH- pack D(UFII PACK-SED) for the pocH-100i automated hematology analyzer

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SULFOLYSER

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

SULFOLYSER - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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SULFOLYSER

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