Emit® 2000 Vancomycin Assay - India CDSCO Medical Device Registration
Emit® 2000 Vancomycin Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_f5ecc6d713d1384c94e6600ef06a23d7_abf66a3cf8fadaba946649e45fd2441b. This device is marketed under the brand name Emit Calibrator/Control Level 4. The license holder is Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Emit Calibrator/Control Level 4
Device Class
Approving Authority
CDSCO
Product Information
The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained by this assay are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy
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