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Random-access chemiluminescence immunoassay system - India CDSCO Medical Device Registration

Random-access chemiluminescence immunoassay system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000206_712717ebbbb045183c01bf62a37dd2d8_cfbd8f6c95dd18f71acd283a13ced2f4. This device is marketed under the brand name HumaCLIA 150 . The license holder is M/s Stedman Pharmaceuticals Pvt. Ltd., and it is classified as Device Class Class A. 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.

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CDSCO Registered
Class Class A
Random-access chemiluminescence immunoassay system
UID: IMP/IVD/2019/000206_712717ebbbb045183c01bf62a37dd2d8_cfbd8f6c95dd18f71acd283a13ced2f4

Brand Name

HumaCLIA 150

Device Class

Class A

Approving Authority

CDSCO

Product Information

HumaCLIA 150 is an automated random-access chemiluminescent immuno-assay (HumaCLIA 150 ) IVD instrument for quantitative, semi-quantitative and qualitative determination of levels or activity of various parameters in human serum, plas-ma, or urine. In combination with HUMAN’s CLIA reagents, it may be used as aid to diagnosis, for screening or monitoring of a range of medical conditions, depending on the used reagent. HumaCLIA 150 is a closed system and can be used with predefined HUMAN CLIA reagents only. For laboratory professional use only

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Products from the same license holder (10 products)

Stand-alone Ion Selective Electrode Electrolyte analyser

Brand: HumaCLIA 150

Class A

Semi-automatic Urine analyser / test strip reader

Brand: HumaCLIA 150

Class A

Clinical Chemistry Analyser

Brand: HumaCLIA 150

Class A

Clinical Chemistry Analyser

Brand: HumaCLIA 150

Class A

Clinical Chemistry Analyser

Brand: HumaCLIA 150

Class A

Fully automated coagulation analyser

Brand: HumaCLIA 150

Class A

Semi-automatic Photometer

Brand: HumaCLIA 150

Class A

Automatic Clinical Chemistry analyser

Brand: HumaCLIA 150

Class A

Hematology Analyser

Brand: HumaCLIA 150

Class A

Hematology Analyser

Brand: HumaCLIA 150

Class A