Starter 1+2 - India CDSCO Medical Device Registration

Starter 1+2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000356_a7d6623ccd897dc1a55bc863460fb47c_cfbc6febcec3bab44a67128fd7c63af0. 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

Starter 1+2

UID: IMP/IVD/2022/000356_a7d6623ccd897dc1a55bc863460fb47c_cfbc6febcec3bab44a67128fd7c63af0

Brand Name

Maglumi 4000 Plus

License Holder

Diatek Healthcare Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

Starter reagent required to generate the chemiluminometric light signal necessary for the implementation of MAGLUMI assays on the MAGLUMI Fully-auto chemiluminescence immunoassay (Maglumi 4000 Plus) analyzer