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CDSCO UID IMP/IVD/2023/000023_b24f4ea45d02eb89c32e4f1a623c0ec9_3f01d38c824af0fb343a9d156bf55b0c

GLYCOHEMOGLOBIN ANALYZER

TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class A·India CDSCO·Brand: A1Chek
Registration details
UID
IMP/IVD/2023/000023_b24f4ea45d02eb89c32e4f1a623c0ec9_3f01d38c824af0fb343a9d156bf55b0c
Device class
Class A
Brand name
A1Chek
License holder
TULIP DIAGNOSTICS PRIVATE LIMITED
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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GLYCOHEMOGLOBIN TEST KIT
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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
Glycohemoglobin Test Strip Kit
Brand: A1Chek
Biosense Technologies Pvt Limited
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About this record

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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