CELLCLEAN - India CDSCO Medical Device Registration

CELLCLEAN is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000255_3a55fcb80b89cd3f4a01f78491abc653_8c862c9b3a454e0001bb60f6c330aa74. 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

CELLCLEAN

UID: IMP/IVD/2019/000255_3a55fcb80b89cd3f4a01f78491abc653_8c862c9b3a454e0001bb60f6c330aa74

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. CELLCLEAN is to be used as a strong alkaline detergent to remove Sysmex lysing reagents, cellular residuals and blood proteins remaining in the hydraulics of Sysmex Fully Automated Hematology Analyzers. CELLCLEAN is to be used as a strong alkaline detergent to clean fluid system components of Sysmex Fully Automated Urine Chemistry Analyzer, Fully Automated Urine Particle Analyzer and Fully Automated Urine Particle Digital Imaging Device. Note: Do not use for UF-500i/1000i and UX-2000

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CELLCLEAN

Brand: Stromatolyser - WH

Sysmex India Private Limited

CELLCLEAN - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CELLCLEAN

CA CLEAN I

CELLSHEATH

CELLPACK DCL

UXII SEARCH-SED

Wash Solution No. 9

SULFOLYSER

CELLPACK

UFII SEARCH-BAC

STROMATOLYSER-NR

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner