Pure Global
CDSCO UID IMP/IVD/2021/000395_db94b19027f85a434c8e6fdc8c007583_791b9d6677a8ac936d4b67b386b1c5cf

HbA1c Rapid Quantitative Test

M/s Vishat Diagnostic Pvt Ltd.·Device Class Class B·India CDSCO·Brand: Biotime
Registration details
UID
IMP/IVD/2021/000395_db94b19027f85a434c8e6fdc8c007583_791b9d6677a8ac936d4b67b386b1c5cf
Device class
Class B
Brand name
Biotime
License holder
M/s Vishat Diagnostic Pvt Ltd.
Approving authority
CDSCO
Product information
It is intended to quantify the percentage of HbA1c in human whole blood on Biotime FIA Analyzer by fluorescent immunoassay.The test is used as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus
Similar products (10)
Other products with the same name or brand
TT4 Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
PRL Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
LH Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
SAA Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
25
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
TT3 Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
CK-MB Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
FSH Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
Myo Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
Ferritin Rapid Quantitative Test
Brand: Biotime
M/s Vishat Diagnostic Pvt Ltd.
Class B
Other products from M/s Vishat Diagnostic Pvt Ltd.
Products from the same license holder (10 products)
Anti-dsDNA IgG
Class B
DHEA
Brand: E1
Class B
AMH
Class B
Anti-SS-B
Class B
Ferritin
Class B
NAISSA System liquid
Class B
NAISSA RSV IgM
Class B
Anti-SS-A
Class B
CCP IgG
Class B
PTH
Class B
About this record

HbA1c Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000395_db94b19027f85a434c8e6fdc8c007583_791b9d6677a8ac936d4b67b386b1c5cf. This device is marketed under the brand name Biotime . The license holder is M/s Vishat Diagnostic Pvt Ltd., 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.