CDSCO UID IMP/IVD/2019/000040_ea0df45e3d15f93f0277fd2ba3647a14_04b149f25007d75aa79d5e925345e0a0

Alpha-Amylase

Beckman Coulter India Private Limited·Device Class Class B·India CDSCO·Brand: COULTER LH Series Pak Reagent Kit
Registration details
UID
IMP/IVD/2019/000040_ea0df45e3d15f93f0277fd2ba3647a14_04b149f25007d75aa79d5e925345e0a0
Device class
Class B
Brand name
COULTER LH Series Pak Reagent Kit
Approving authority
CDSCO
Product information
Kinetic colour test for the quantitative determination of α-amylase, [1,4-α-D-glucan 4-glucanohydrolase, EC 3.2.1.1], in human serum, plasma and urine on Beckman Coulter analysers
Similar products (10)
Other products with the same name or brand
Prealbumin Calibrator
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
D-Dimer Control
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
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
Class B
LIPASE
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
Serum Protein Multi-Calibrator 2
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
Access TPO Antibody
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
D-Dimer Calibrator
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
RF Latex
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
CRP Latex Calibrator Normal Set(CRP Latex Calibrator Normal Set)-The CRP Calibrator is a liquid human serum based matrix calibrator intended to be used with the Normal application of the CRP reagent OSR6x99 for the quantitative determination of CRP on Beckman Coulter AU analysers.,α-1 ACIDGLYCOPROTEIN
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
Prealbumin
Brand: COULTER LH Series Pak Reagent Kit
Beckman Coulter India Private Limited
Class B
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
Class B
Compensation setup Reagent
Brand: ClearLLab Compensation kit
Class C
Reagent for aid to differential diagnosis of hematopoietic neoplasms
Brand: ClearLLab Compensation kit
Class C
Reagent for aid to differential diagnosis of hematopoietic neoplasms
Brand: ClearLLab Compensation kit
Class C
Haematolymphoid malignancies screening Reagent
Brand: ClearLLab Compensation kit
Class C
DxFLEX Flow Cytometer Instrument
Brand: DxFLEX Flow Cytometer Instrument
Class A
DxFLEX Flow Cytometer Instrument
Brand: DxFLEX Flow Cytometer Instrument
Class A
Power Link
Brand: Power Link
Class A
Power Express
Brand: Power Link
Class A
CellaVision DM9600
Brand: CellaVision DM9600
Class A
About this record

Alpha-Amylase is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_ea0df45e3d15f93f0277fd2ba3647a14_04b149f25007d75aa79d5e925345e0a0. 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.