UF-CELLSHEATH - India CDSCO Medical Device Registration

UF-CELLSHEATH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000157_8019d1f208b9387186836b640627f767_f598b4af31dba8dd6b5cf100e25baf5e. 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

UF-CELLSHEATH

UID: IMP/IVD/2019/000157_8019d1f208b9387186836b640627f767_f598b4af31dba8dd6b5cf100e25baf5e

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 UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cytometry method

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UF-CELLSHEATH

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

UF-CELLSHEATH - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

UF-CELLSHEATH

CELLPACK DCL

SULFOLYSER

CELLPACK

STROMATOLYSER-4DL

STROMATOLYSER-WH

CELLPACK DFL

UXII SHEATH

UFII SHEATH

UFII PACK-SED

CELLPACK DCL

CELLPACK

Stromatolyser - FB

Stromatolyser - 4DL

Stromatolyser - WH

CELLCLEAN

INNOVANCE PFA-200

Rotolavit II-S

Sheath Fluid

Semi-automated Blood Coagulation Analyzer CA-101