SGTi-flex COVID-19 IgM/IgG - Indonesia BPOM Medical Device Registration
SGTi-flex COVID-19 IgM/IgG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024577. The device is manufactured by SUGENTECH, INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SOMETECH NEW Zealand.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SUGENTECH, INC.Country of Origin
Korea
Authorized Representative
PT. SOMETECH NEW ZealandAR Address
AKR Tower Lantai 11 Unit 11G, Jl. Panjang No. 5
Registration Date
Jun 18, 2021
Expiry Date
Jul 09, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
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