Congenital defect/syndrome risk assessment interpretive software - India CDSCO Medical Device Registration

Congenital defect/syndrome risk assessment interpretive software is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000467_3172ee26119303b99eba22688134fe5a_314ceb1b5ae9e3990a03db541a5a066b. This device is marketed under the brand name B.RA.H.M.S Fast Screen pre-I plus. The license holder is CPC DIAGNOSTICS PVT.LTD, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Congenital defect/syndrome risk assessment interpretive software

UID: IMP/IVD/2023/000467_3172ee26119303b99eba22688134fe5a_314ceb1b5ae9e3990a03db541a5a066b

Brand Name

B.RA.H.M.S Fast Screen pre-I plus

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

B·R·A·H·M·S Fast Screen pre-I plus is a software for non-invasive risk assessment of foetal trisomy 21, 18 and 13 in the 1st, of trisomy 21, 18 and foetal neural tube defect in the 2nd trimester of pregnancy as well as for 1st trimester risk assessment for developing pre-eclampsia (B.RA.H.M.S Fast Screen pre-I plus). By using B·R·A·H·M·S Fast Screen pre-I plus 3.0 or 3.1, an individual risk regarding the foetal trisomy 21, 18 and 13 is calculated in pregnant women from parameters such as maternal characteristics, sonographic measurements and biochemical determination of maternal serum markers, measured on B·R·A·H·M·S KRYPTOR systems. The result of the risk calculation serves as a basis for considering further diagnostic measures; it is not conclusive for the presence of a trisomy 21, 18 and 13 in the foetus. The value of maternal AFP in the 2nd trimester of pregnancy can also indicate a fatal neural tube defect requiring further non-invasive and/or invasive examinations for diagnosis. The individual risk of pregnant women for developing pre-eclampsia is calculated based on parameters such as maternal characteristics, sonographic measurements, physiological markers and biochemical determination of maternal serum markers, measured on B·R·A·H·M·S KRYPTOR systems.