Emit II Plus Methaqualone Assay - India CDSCO Medical Device Registration
Emit II Plus Methaqualone Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000832_c2f4b50cc041763d56cd22d23685d32e_0fd159342704f3b562a25c7973f82daf. 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 comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. 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.
Brand Name
Emit Calibrator/Control Level 4
Device Class
Approving Authority
CDSCO
Product Information
The Emit II Plus Methaqualone 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 methaqualone in human urine. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems. The Emit ® II Plus Methaqualone 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 Ethyl Alcohol Negative Calibrator
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit Amikacin Assay
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit II Plus Opiate Assay
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit Calibrator/Control Level 5
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit II Plus Barbiturate Assay
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit II Plus Ecstasy Assay
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit® 2000 Vancomycin Assay
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit 2000 Valproic Acid Calibrators
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Emit Ethyl Alcohol 100 mg/dL Calibrator
Brand: Emit Calibrator/Control Level 4
Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Access C-Peptide
Brand: Access C-Peptide
Access C-Peptide Calibrators
Brand: Access C-Peptide
Emit Ethyl Alcohol Negative Calibrator
Brand: Emit Calibrator/Control Level 4
Emit Amikacin Assay
Brand: Emit Calibrator/Control Level 4
Emit II Plus Opiate Assay
Brand: Emit Calibrator/Control Level 4
Emit Calibrator/Control Level 5
Brand: Emit Calibrator/Control Level 4
Emit II Plus Barbiturate Assay
Brand: Emit Calibrator/Control Level 4
Emit II Plus Ecstasy Assay
Brand: Emit Calibrator/Control Level 4
Emit® 2000 Vancomycin Assay
Brand: Emit Calibrator/Control Level 4
Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1
Brand: Emit Calibrator/Control Level 4