Instrument - India CDSCO Medical Device Registration
Instrument is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000056_4bad3e7b155943ebf27d1da56ae2e258_6cc82c56ada6eef397182cf4b4b1f4a2. This device is marketed under the brand name Ichroma™ II. The license holder is M/s SPARK SCIENTIFIC PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is CDSCO.
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Brand Name
Ichroma™ II
License Holder
M/s SPARK SCIENTIFIC PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
ichroma™ II is a semi-auto fluorescence and Europium nanoparticle scanning instrument for use with various ichroma™ immunoassay test(Ichroma™ II) for measuring the concentration of designated analytes in the human blood, urine and other specimens; if duly tested according to the test procedure recommended by Boditech Med Incorporated.
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