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HbA1c Rapid Quantitative Test-It is intended to quantify the percentage of HbA1c in human whole blood on Biotime FIA Analyzer by fluorescent immunoassay.The test is used as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus.,β-hCG Rapid Quantitative Test - India CDSCO Medical Device Registration

HbA1c Rapid Quantitative Test-It is intended to quantify the percentage of HbA1c in human whole blood on Biotime FIA Analyzer by fluorescent immunoassay.The test is used as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus.,β-hCG Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000035_457ecd90cd552e89fc273215d9ff2a00_44fd7d0d4aaf09ca6c9cf9bf7ceefe88. This device is marketed under the brand name Immunoglobulin E. The license holder is DIYA SCIENTIFIC, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
HbA1c Rapid Quantitative Test-It is intended to quantify the percentage of HbA1c in human whole blood on Biotime FIA Analyzer by fluorescent immunoassay.The test is used as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus.,β-hCG Rapid Quantitative Test
UID: IMP/IVD/2022/000035_457ecd90cd552e89fc273215d9ff2a00_44fd7d0d4aaf09ca6c9cf9bf7ceefe88

Brand Name

Immunoglobulin E

License Holder

DIYA SCIENTIFIC

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Biotime β-hCG (Immunoglobulin E) Rapid Quantitative Test is intended to quantify the concentration of total β-hCG in human serum or plasma on Biotime FIA Analyzers by fluorescent immunoassay. The test is used as an aid detection of early pregnancy, embryonic development and ectopic pregnancy. -Fluorescent immunoassay -Early pregnancy, embryonic development and ectopic pregnancy For in vitro diagnostic use only. For professional use only

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