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CDSCO UID IMP/IVD/2020/000832_f8c2e5e06261c9c8edc43bf2b557114e_810793ccf28032f61734dfb8404890e0

Emit II Plus Ecstasy Assay

Beckman Coulter India Private Limited Hisaria Warehouse Ground FloorDevice Class Class CIndia CDSCOBrand: Emit Calibrator/Control Level 4
VerifiedCDSCO · official registry
Registration details
UID
IMP/IVD/2020/000832_f8c2e5e06261c9c8edc43bf2b557114e_810793ccf28032f61734dfb8404890e0
Device class
Class C
Brand name
Emit Calibrator/Control Level 4
License holder
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Approving authority
CDSCO
Product information
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of methylenedioxymethamphetamine (Emit Calibrator/Control Level 4) and closely related drugs in human urine. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems
About this record

Emit II Plus Ecstasy Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_f8c2e5e06261c9c8edc43bf2b557114e_810793ccf28032f61734dfb8404890e0. 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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