Immunoturbidimetric analyser - India CDSCO Medical Device Registration

Immunoturbidimetric analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000043_cc030a934a29dae46bd820c23cafd99d_60ba409a966f270bfeefce3c7fcea07e. This device is marketed under the brand name HbChek-Control Strips. The license holder is Biosense Technologies Pvt.ltd, and it is classified as Device Class Class A. The approving authority is Kokan Division.

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CDSCO Registered

Class Class A

Immunoturbidimetric analyser

UID: MFG/IVD/2022/000043_cc030a934a29dae46bd820c23cafd99d_60ba409a966f270bfeefce3c7fcea07e

Brand Name

HbChek-Control Strips

License Holder

Biosense Technologies Pvt.ltd

Device Class

Class A

Approving Authority

Kokan Division

Product Information

A light scattering analyzer that quantifies the analytes in the body fluid by measuring the light scattering intensity from the immune complex generated in the reaction between analyte and antibody. The TURBIDIMETRY AND NEPHELOMETRY ANALYSER is used to analyse various immunochemistry analytes such as RF, CRP, ASO, MA, D-DIMER, Hba1c, Cystatin C, C3, C4, IgE by turbidimetric or nephelometric assays