The TREC, KREC quantitative DNA test and the qualitative test for the exon 7 of the SMN1 gene and the RPP30 gene - Vietnam Registration 240001452/PCBB-HN
Access comprehensive regulatory information for The TREC, KREC quantitative DNA test and the qualitative test for the exon 7 of the SMN1 gene and the RPP30 gene in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001452/PCBB-HN and manufactured by Wallac Oy. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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Device Details
Registration Details
240001452/PCBB-HN
000.00.19.H26-240611-0032
Eonis SCID-SMA kit
3241-0020
Technical Details
It is used for the semiquantitative detection of TREC (T-cell receptor excision circle) and KREC (Kappa-deleting recombination excision circle) and the qualitative analysis of the exon 7 of the SMN1 gene and the RPP30 gene (Ribonuclease P/MRP subunit P30) in DNA from dried blood spots on filter paper, supporting the screening for Combined Immunodeficiency (CID) with severe combined immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and Spinal Muscular Atrophy (SMA) in newborns.
Dates and Status
Jun 19, 2024