GEM ® CVP 5 tBili - India CDSCO Medical Device Registration
GEM ® CVP 5 tBili is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000615_f9ae032fb577693fd8258f6522e6204a_b8d2d9eb5dd70a7266e8db669da2827b. This device is marketed under the brand name HemosIL. The license holder is Instrumentation Laboratory India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
HemosIL
License Holder
Instrumentation Laboratory India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
External Calibration Valuation Product used to complete the calibration process of GEM Premier 4000 and GEM Premier 5000* analyzers prior to use with patient samples for total bilirubin (HemosIL) testing
HemosIL QFA Thrombin
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
HemosIL Direct Thrombin Inhibitor Assay
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
HemosIL Factor II Deficient Plasma
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
GEM PREMIER 5000 PAK pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 - 75 Test
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
Electrachrome Factor VIII
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
HemosIL Silica Clotting Time
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
HemosIL Factor Diluent
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
GEM PREMIER 5000 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 - 75 Test
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
GEM PREMIER 5000 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 - 75 Test
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
HemosIL Factor V Leiden
Brand: HemosIL
Instrumentation Laboratory India Pvt Ltd
ROTROL N
Brand: ROTEM®
ROTEM® sigma ROTROL N
Brand: ROTEM®
ROTROL P
Brand: ROTEM®
sigma complete + hep
Brand: ROTEM®
ROTEM® sigma ROTROL P
Brand: ROTEM®
Albumin
Brand: quantILab
Direct Bilirubin
Brand: quantILab
TIBC
Brand: quantILab
Calcium Arsenazo
Brand: quantILab
Amylase
Brand: quantILab