CDSCO UID IMP/IVD/2020/000832_e6db1ced4290a67273a967f35a62f556_d388346abb711e5ad85a0f798b51f6a9Emit II Plus Propoxyphene Assay
- UID
- IMP/IVD/2020/000832_e6db1ced4290a67273a967f35a62f556_d388346abb711e5ad85a0f798b51f6a9
- Device class
- Class C
- Brand name
- Emit Calibrator/Control Level 4
- Approving authority
- CDSCO
- Product information
- The Emit® II Plus Propoxyphene Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of propoxyphene in human urine. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems. The Emit® II Plus Propoxyphene 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. 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 Propoxyphene Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_e6db1ced4290a67273a967f35a62f556_d388346abb711e5ad85a0f798b51f6a9. 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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