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Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test - India CDSCO Medical Device Registration

Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000481_057f2bbc2966701510d293018ec2ddd9_d5e2a2721708347c3989a5f6f6b6fae3. This device is marketed under the brand name Combinatorial Probe-Anchor Synthesis Sequencing Method. The license holder is Rivaara Labs Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test
UID: IMP/IVD/2021/000481_057f2bbc2966701510d293018ec2ddd9_d5e2a2721708347c3989a5f6f6b6fae3

Brand Name

Combinatorial Probe-Anchor Synthesis Sequencing Method

Device Class

Class C

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. This kit is to prenatally assessing the fetal risk of Down syndrome (Combinatorial Probe-Anchor Synthesis Sequencing Method), Edwards syndrome (Combinatorial Probe-Anchor Synthesis Sequencing Method) and Patau syndrome (Combinatorial Probe-Anchor Synthesis Sequencing Method) in high-risk pregnant women with more than 12 weeks of pregnancy. This is achieved through analyzing the differences in the number of chromosomes 21, 18 and 13 in the cell-free fetal DNA in maternal plasma samples, to perform prenatal screening for trisomies of chromosomes 21, 18 and 13 (Combinatorial Probe-Anchor Synthesis Sequencing Method). This kit is used to prepare a sequencing DNA library of cell free DNA. This kit shall be used according to industry norms

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