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
- Device class
- Class B
- Brand name
- Immunoglobulin E
- License holder
- DIYA SCIENTIFIC
- 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
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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