STROMATOLYSER-4DL - India CDSCO Medical Device Registration

STROMATOLYSER-4DL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000157_d203df51205368f777f763a95013d520_774e4cc71ce4281b14b06e3dd49bee24. 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-4DL

UID: IMP/IVD/2019/000157_d203df51205368f777f763a95013d520_774e4cc71ce4281b14b06e3dd49bee24

Brand Name

UFII PACK-SED

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count and WBC count with Sysmex automated hematology analyzers (UFII PACK-SED)

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STROMATOLYSER-4DL

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

STROMATOLYSER-4DL - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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STROMATOLYSER-4DL

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