CDSCO UID IMP/IVD/2019/000255_d886bdaeae0332d63cbde96c849cdd85_691c90be1e5b0f35525189b56efbdf2a

STROMATOLYSER-NR

Sysmex India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: UXII PACK-SED
Registration details
UID
IMP/IVD/2019/000255_d886bdaeae0332d63cbde96c849cdd85_691c90be1e5b0f35525189b56efbdf2a
Device class
Class B
Brand name
UXII PACK-SED
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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About this record

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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