β-hCG pregnancy test - India CDSCO Medical Device Registration

β-hCG pregnancy test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000127_514b7844c2fb5626469a495e0072b633_9bd65a4479256237b72d494edd12fa4e. This device is marketed under the brand name Q-Line. The license holder is KUTE WELLNESS INC, and it is classified as Device Class Class B. The approving authority is North Delhi Division.

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CDSCO Registered

Class Class B

β-hCG pregnancy test

UID: MFG/IVD/2020/000127_514b7844c2fb5626469a495e0072b633_9bd65a4479256237b72d494edd12fa4e

Brand Name

Q-Line

License Holder

KUTE WELLNESS INC

Device Class

Class B

Approving Authority

North Delhi Division

Product Information

Q-line® Human chorionic gonadotropin (Q-Line) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception (Q-Line). hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period (Q-Line), and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.