STROMATOLYSER-NR - India CDSCO Medical Device Registration

STROMATOLYSER-NR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000255_d886bdaeae0332d63cbde96c849cdd85_691c90be1e5b0f35525189b56efbdf2a. 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

STROMATOLYSER-NR

UID: IMP/IVD/2019/000255_d886bdaeae0332d63cbde96c849cdd85_691c90be1e5b0f35525189b56efbdf2a

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. STROMATOLYSER-NR is to be used to dilute the sample while simultaneously staining the nucleated cells for the assay of NRBC count and NRBC percent in blood with selected Sysmex automated hematology analysers. STROMATOLYSER-NR is a pre-packaged reagent kit consisting of STROMATOLYSER-NR LYSING REAGENT buffer and STROMATOLYSER-NR DYE

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CA CLEAN I

Brand: UXII PACK-SED

Sysmex India Pvt. Ltd.

STROMATOLYSER-NR - 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

LYSERCELL WPC

STROMATOLYSER-4DL

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner