CDSCO UID IMP/IVD/2020/000832_c933e8a2ee07388af7262d74c04f000f_cb8a1848caeee4021831857888448cb7Emit tox™ Serum Barbiturate Assay
- UID
- IMP/IVD/2020/000832_c933e8a2ee07388af7262d74c04f000f_cb8a1848caeee4021831857888448cb7
- Device class
- Class C
- Brand name
- Emit Calibrator/Control Level 4
- Approving authority
- CDSCO
- Product information
- The Emit® tox™ Serum Barbiturate Assay is a homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of specific barbiturates in human serum or plasma. This assay is designed for use with most chemistry analyzers. The Emit® tox™ Serum 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. 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 tox™ Serum Barbiturate Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_c933e8a2ee07388af7262d74c04f000f_cb8a1848caeee4021831857888448cb7. 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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