Pure Global

Calibration set - India CDSCO Medical Device Registration

Calibration set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000067_ce42386331df15894f8c982157e7a9ea_2d781924bb7b8d5a1c34440e39a03452. This device is marketed under the brand name Diatro Lyse-5P. The license holder is Genworks Health 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class B
Calibration set
UID: IMP/IVD/2022/000067_ce42386331df15894f8c982157e7a9ea_2d781924bb7b8d5a1c34440e39a03452

Brand Name

Diatro Lyse-5P

Device Class

Class B

Approving Authority

CDSCO

Product Information

Calibration set is a set of solutions for the Pictus family analyzer systemperformance preprogrammed tests. The set is containing 50 g/L sodiumnitrite aqueous solution for stray light tests and potassium dichromatecalibration solution set for photometer stability test, dilutor linearity test,photometer linearity test and photometer noise test. Calibration set shouldbe used with only Diatron reagents. Erroneous results may be obtained ifthe reagent is applied with third party reagents

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing