Glycosylated Hemoglobin Test Kit - Latex Immuno Turbidimetric method - India CDSCO Medical Device Registration

Glycosylated Hemoglobin Test Kit - Latex Immuno Turbidimetric method is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000128_8f566c9f3949e16a83cd699376252fb7_bf2e8f7f9c11d8d56215cde361f975aa. This device is marketed under the brand name HbA1c. The license holder is BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Tamil Nadu.

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CDSCO Registered

Class Class B

Glycosylated Hemoglobin Test Kit - Latex Immuno Turbidimetric method

UID: MFG/IVD/2020/000128_8f566c9f3949e16a83cd699376252fb7_bf2e8f7f9c11d8d56215cde361f975aa

Brand Name

HbA1c

License Holder

BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED

Device Class

Class B

Approving Authority

Tamil Nadu

Product Information

Quantitative assay for measuring concentrations of Hemoglobin A1c in blood

DJ Fang

MedTech Regulatory Expert

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