Anti-HBe (MAGLUMI® Anti-HBe ) - India CDSCO Medical Device Registration
Anti-HBe (MAGLUMI® Anti-HBe ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000036_c2d3f1f013c4468c98100037868ae867_72a369760b3f3b900a0a005ed97367f9. This device is marketed under the brand name CLIA. The license holder is SNIBE DIAGNOSTIC (India) Private Limited., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
CLIA
License Holder
SNIBE DIAGNOSTIC (India) Private Limited.Device Class
Approving Authority
CDSCO
Product Information
The kit is an in vitro chemiluminescence immunoassay for the qualitative determination of Anti-HBe in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated System, and the assay is used as an aid in the diagnosis of HBV infection
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