Emit II Plus Ecstasy Assay
- UID
- IMP/IVD/2020/000832_f8c2e5e06261c9c8edc43bf2b557114e_810793ccf28032f61734dfb8404890e0
- Device class
- Class C
- Brand name
- Emit Calibrator/Control Level 4
- Approving authority
- CDSCO
- Product information
- The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of methylenedioxymethamphetamine (Emit Calibrator/Control Level 4) and closely related drugs in human urine. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems
Emit II Plus Ecstasy Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_f8c2e5e06261c9c8edc43bf2b557114e_810793ccf28032f61734dfb8404890e0. 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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