CDSCO UID IMP/IVD/2020/000832_f9cb78825946e3fc62d3782aee2f46a1_98df272658ea814344cf36e7c28d6b7bEmit II Plus Barbiturate Assay
- 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
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.
This page provides the facts attached to this CDSCO registry row. Other records from the same license holder are available through the database search link without adding aggregation queries to this page. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.