Light Check - India CDSCO Medical Device Registration
Light Check is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000256_6910b330a630ee774a67b011c6e819fa_d69e7749a535f12fd64dfa17289cca11. This device is marketed under the brand name MAGLUMI. The license holder is M/s Avantor Performance Materials India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
MAGLUMI
License Holder
M/s Avantor Performance Materials India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Light Check reagent required to check the validity of Starter 1+2 as well as the functioning of the measuring and pipetting units. A Light Check has to be carried out on the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer (MAGLUMI) and Biolumi series Integrated System (MAGLUMI) either once daily prior to starting the first measurement or whenever a new lot of starter reagents is used. This control program checks the proper functioning of the instrument and starter reagents to avoid data error due to instrument defects or mislocated or expired starter reagents
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