ORAgene -DNA for assisted collection of human DNA - Indonesia BPOM Medical Device Registration
ORAgene -DNA for assisted collection of human DNA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10203020153. The device is manufactured by DNA GENOTEK INC. from Canada, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. SCIENCEWERKE.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
DNA GENOTEK INC.Country of Origin
Canada
Authorized Representative
PT. SCIENCEWERKEAR Address
Jl.Palmerah Barat No.25
Registration Date
Oct 24, 2022
Expiry Date
Jun 16, 2027
Product Type
Pathology Equipment and Accessories
Specimen transport and storage container.
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