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CDSCO UID MFG/IVD/2019/000001_13a8285effd1e53de10fbb91ba00d043_c4df6fdc9885c42ea26ed8b9d5ebda4a

Glutamic Acid Decarboxylase Test

Diabetomics Medical (P) Ltd·Device Class Class B·India CDSCO·Brand: Lumella
Registration details
UID
MFG/IVD/2019/000001_13a8285effd1e53de10fbb91ba00d043_c4df6fdc9885c42ea26ed8b9d5ebda4a
Device class
Class B
Brand name
Lumella
License holder
Diabetomics Medical (P) Ltd
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
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About this record

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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