Glutamic Acid Decarboxylase Test - India CDSCO Medical Device Registration
Glutamic Acid Decarboxylase Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000001_13a8285effd1e53de10fbb91ba00d043_c4df6fdc9885c42ea26ed8b9d5ebda4a. This device is marketed under the brand name Lumella. The license holder is Diabetomics Medical (P) Ltd, and it is classified as Device Class Class B. The approving authority is Telangana.
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Brand Name
Lumella
License Holder
Diabetomics Medical (P) LtdDevice Class
Approving Authority
Telangana
Product Information
The Insudex® GAD Test is for the semi-quantitative determination of glutamic acid decarboxylase antibody (Lumella) in human serum. The assay is useful as an aid in the diagnosis of Type I diabetes mellitus (Lumella). The GAD Test is not to be used alone and is to be used in conjunction with other clinical and laboratory findings
