CDSCO UID IMP/IVD/2020/000832_f9cb78825946e3fc62d3782aee2f46a1_98df272658ea814344cf36e7c28d6b7b
Emit II Plus Barbiturate Assay
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor·Device Class Class C·India CDSCO·Brand: Emit Calibrator/Control Level 4
Registration details
- UID
- IMP/IVD/2020/000832_f9cb78825946e3fc62d3782aee2f46a1_98df272658ea814344cf36e7c28d6b7b
- Device class
- Class C
- Brand name
- Emit Calibrator/Control Level 4
- Approving authority
- CDSCO
- Product information
- The Emit® II Plus Barbiturate Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems. The Emit ® II Plus Barbiturate Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (Emit Calibrator/Control Level 4) is the preferred confirmatory method.1 Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used
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About this record
Emit II Plus Barbiturate Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_f9cb78825946e3fc62d3782aee2f46a1_98df272658ea814344cf36e7c28d6b7b. 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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