IVD software - India CDSCO Medical Device Registration

IVD software is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000407_5df24cfae9fa37c758dd86f17e710e3f_6bacdcd7b97e8856afc9774881578afb. This device is marketed under the brand name HB&L UROQUATTRO LIGHT. The license holder is Suyog Diagnostic Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

IVD software

UID: IMP/IVD/2023/000407_5df24cfae9fa37c758dd86f17e710e3f_6bacdcd7b97e8856afc9774881578afb

Brand Name

HB&L UROQUATTRO LIGHT

License Holder

Suyog Diagnostic Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

I-dOne is an IVD software for qualitative analysis, meant for clinical laboratory professional users, for the identification of bacteria, fungi and yeasts of isolates from positive cultures of biological samples, by means of the interpretation of ATR-FTIR spectra (HB&L UROQUATTRO LIGHT)