Prealbumin - India CDSCO Medical Device Registration

Prealbumin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_95e6c503fbc5db9afc69a0e16ad878dd_c0a291c8a67dd1cee8fb6cf598317b7a. This device is marketed under the brand name COULTER LH Series Pak Reagent Kit. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. 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.

Free Database

Powered by Pure Global AI

CDSCO Registered

Class Class B

Prealbumin

UID: IMP/IVD/2019/000040_95e6c503fbc5db9afc69a0e16ad878dd_c0a291c8a67dd1cee8fb6cf598317b7a

Brand Name

COULTER LH Series Pak Reagent Kit

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Immuno-turbidimetric test for the quantitative determination of prealbumin in human serum on Beckman Coulter AU analysers

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Similar Products (10)

Other products with the same name or brand

Prealbumin

PARIKSHA BIOTECH PRIVATE LIMITED

Prealbumin

Brand: ARCHTECT Total T4 Controls

Abbott Healthcare Pvt. Ltd.

Prealbumin

Brand: ARCHTECT Total T4 Controls

Abbott Healthcare Pvt. Ltd.

Prealbumin

Brand: Apolipoprotein B

Abbott Healthcare Pvt. Ltd.

Prealbumin

Brand: DILUENT/SHEATH

Abbott Healthcare Pvt. Ltd.

Prealbumin

Brand: Alinity c Activated Aspartate Aminotransferase Reagent Kit

Abbott Healthcare Pvt. Ltd.

Prealbumin Calibrator

Brand: COULTER LH Series Pak Reagent Kit

Beckman Coulter India Private Limited

Alpha-Amylase

Brand: COULTER LH Series Pak Reagent Kit

Beckman Coulter India Private Limited

D-Dimer Control

Brand: COULTER LH Series Pak Reagent Kit

Beckman Coulter India Private Limited

Access Total BhCG (Access Total BhCG )-The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy. The concentration of BhCG determined by this kit can also be used in conjunction with AFP, unconjugated estriol, and Inhibin A concentrations in Down syndrome risk assessment. Such an approach has been verified on the basis of multivariate Gaussian distribution analysis.,ß-2 MICROGLOBULIN

Brand: COULTER LH Series Pak Reagent Kit

Beckman Coulter India Private Limited

Other Products from Beckman Coulter India Private Limited

Products from the same license holder (10 products)

DURAClone B27 Reagent Kit

Brand: DURAClone B27 Reagent Kit

Compensation setup Reagent

Brand: ClearLLab Compensation kit

Reagent for aid to differential diagnosis of hematopoietic neoplasms

Brand: ClearLLab Compensation kit

Reagent for aid to differential diagnosis of hematopoietic neoplasms

Brand: ClearLLab Compensation kit

Haematolymphoid malignancies screening Reagent

Brand: ClearLLab Compensation kit

DxFLEX Flow Cytometer Instrument

Brand: DxFLEX Flow Cytometer Instrument

DxFLEX Flow Cytometer Instrument

Brand: DxFLEX Flow Cytometer Instrument

Power Link

Brand: Power Link

Power Express

Brand: Power Link

CellaVision DM9600

Brand: CellaVision DM9600