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/2022/000356_6910b330a630ee774a67b011c6e819fa_a676527f911e9aa73a49c34458e57cff. This device is marketed under the brand name Maglumi 4000 Plus. The license holder is Diatek Healthcare Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Light Check

UID: IMP/IVD/2022/000356_6910b330a630ee774a67b011c6e819fa_a676527f911e9aa73a49c34458e57cff

Brand Name

Maglumi 4000 Plus

License Holder

Diatek Healthcare Private Limited

Device Class

Class A

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 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