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/2019/000255_8019d1f208b9387186836b640627f767_c811bf4b5d3612d7fc8ef35dcd0c7e4d. 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

UF-CELLSHEATH

UID: IMP/IVD/2019/000255_8019d1f208b9387186836b640627f767_c811bf4b5d3612d7fc8ef35dcd0c7e4d

Brand Name

UXII PACK-SED

License Holder

Sysmex India Pvt. Ltd.

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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CA CLEAN I

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

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