GeneBio HCG Pregnancy Rapid
- UID
- MFG/IVD/2023/000091_82ffae6d11edd24cd1d33f30085dd57f_ee6dcd2e79ae80203b025ad81932f5b5
- Device class
- Class B
- Brand name
- GeneBio
- License holder
- GeneBio Healthare Pvt Ltd
- Approving authority
- Uttar Pradesh
- Product information
- hCG Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The hCG Rapid Test is not intended for quantitative results, It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human urine. The hCG detection limit the hCG Rapid Test is 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result
GeneBio HCG Pregnancy Rapid is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000091_82ffae6d11edd24cd1d33f30085dd57f_ee6dcd2e79ae80203b025ad81932f5b5. This device is marketed under the brand name GeneBio. The license holder is GeneBio Healthare Pvt Ltd, and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.
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