Lyse(Norma-iLyse5 OP ) - India CDSCO Medical Device Registration
Lyse(Norma-iLyse5 OP ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000087_acf6ac206885db38d1a1f1304986f77d_aadb9072eec0c6d10d47e7736936a46f. This device is marketed under the brand name NIC-0P32L. The license holder is SOWAR PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
NIC-0P32L
License Holder
SOWAR PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
Norma-iLyse5 OP lysing reagent is a stabilized and micro-filtered lysing agent for stromatolysis of erythtrocytes (NIC-0P32L), for quantitative determination of leukocytes (NIC-0P32L), leukocyte five-part differentiation (NIC-0P32L) and hemoglobin (NIC-0P32L) concentration measurement in human blood on Norma Icon-5 OP haematology analysers. ,hypochlorite cleaner(Norma-iHClean (NIC-0P32L))-orma-iHClean hypochlorite cleaning reagent is a stabilized and micro-filtered hypochlorite solution for intensive oxidative cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on Norma haematology analysers. Norma-iHClean hypochlorite cleaning reagent should only be used with Norma reagents. Erroneous results may be obtained if the reagent is applied with third party reagents
Control Blood(NormaCont3+ KIT K3 )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Control Blood(NormaCont3+ KIT K2 )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Cleaner(Norma-iClean5 OP )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Control blood(NormaCont5+ high 3ml )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Cleaner(Norma-iSol3 )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Cleaner(Norma-iSol3 )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Diluent(Norma-iDil5 OP )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Control blood(NormaCont5+ KIT KN )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Reagent Pack(Norma-iRP51 OP )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Control Blood(NormaCont3+ KIT K1 )
Brand: NIC-0P32L
SOWAR PRIVATE LIMITED
Cartridge
Brand: e|1 QC Level 3
QC Material
Brand: e|1 QC Level 3
Electrolyte Analyzer
Brand: EXIAS e|1 Analyzer
Capillary tubes
Brand: e|1 QC Level 3
Control Blood(NormaCont3+ KIT K3 )
Brand: NIC-0P32L
Control Blood(NormaCont3+ KIT K2 )
Brand: NIC-0P32L
Cleaner(Norma-iClean5 OP )
Brand: NIC-0P32L
Control blood(NormaCont5+ high 3ml )
Brand: NIC-0P32L
Cleaner(Norma-iSol3 )
Brand: NIC-0P32L
Cleaner(Norma-iSol3 )
Brand: NIC-0P32L