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Total IgE - India CDSCO Medical Device Registration

Total IgE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000059_395d78a836b776f85b4e854be563f77f_938d894d4a735e23874de2b8d96051b4. This device is marketed under the brand name ichroma™ ST2. The license holder is Kin Diagnostics, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Total IgE
UID: IMP/IVD/2020/000059_395d78a836b776f85b4e854be563f77f_938d894d4a735e23874de2b8d96051b4

Brand Name

ichroma™ ST2

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ Total IgE is a fluorescence immunoassay (ichroma™ ST2) for the quantitative determination of total IgE in human whole blood/serum/ plasma. It is useful as an aid in diagnosis and management of allergic disease. For in vitro diagnostic use only

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