GLYCOHEMOGLOBIN ANALYZER - India CDSCO Medical Device Registration

GLYCOHEMOGLOBIN ANALYZER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000023_b24f4ea45d02eb89c32e4f1a623c0ec9_3f01d38c824af0fb343a9d156bf55b0c. This device is marketed under the brand name A1Chek. The license holder is TULIP DIAGNOSTICS 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

GLYCOHEMOGLOBIN ANALYZER

UID: IMP/IVD/2023/000023_b24f4ea45d02eb89c32e4f1a623c0ec9_3f01d38c824af0fb343a9d156bf55b0c

Brand Name

A1Chek

License Holder

TULIP DIAGNOSTICS PRIVATE LIMITED

Device Class

Class A

Approving Authority

CDSCO

Product Information

A1Chek Analyzer is for use with A1chek glycohemoglobin test kit to quantitatively measure the HbA1c in human capillary blood or venous blood. This analyzer is applicable to: HbA1c monitoring conducted by clinical medical professionals, or self monitoring by patients with diabetes or high-risk groups. This analyzer is not applicable for the diagnosis of diabetes.

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Pricing

GLYCOHEMOGLOBIN TEST KIT

Brand: A1Chek

TULIP DIAGNOSTICS PRIVATE LIMITED

Class B

Glycohemoglobin Test Kit

Brand: A1Chek

Biosense Technologies Pvt Ltd ,Building No A-9, Gala No.39-40, 139-140, 239-240 Bhumi World Industrial Park, Mumbai Nashik Highway, Pimplas Village, Bhiwandi, Thane-421302. ,Thane Maharashtra ,421302 ,India

Class B