Emit Calibrator/Control Level 1
- UID
- IMP/IVD/2020/000832_d417b00ca753057bd0ba4d9a814b705f_703139bbcf493b6859d0a7cdb01791da
- Device class
- Class C
- Brand name
- Emit Calibrator/Control Level 4
- Approving authority
- CDSCO
- Product information
- The Emit® Calibrators/Controls are used in the calibration of the Emit® II Plus Amphetamines, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Ecstasy, Methadone, Methaqualone, Monoclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays. These standards may also be used as quality control materials based upon specified assay cutoff levels for the Emit® II Plus drugs-of-abuse assays
Emit Calibrator/Control Level 1 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_d417b00ca753057bd0ba4d9a814b705f_703139bbcf493b6859d0a7cdb01791da. 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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