EasyNAT Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay) - Indonesia BPOM Medical Device Registration
EasyNAT Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024863. The device is manufactured by USTAR BIOTECHNOLOGIES (HANGZHOU) LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INODIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
USTAR BIOTECHNOLOGIES (HANGZHOU) LTDCountry of Origin
China
Authorized Representative
PT. INODIAAR Address
Perkantoran Kedoya Elok Plaza Blok DB no 24, Jalan Panjang, Kebon Jeruk
Registration Date
May 11, 2021
Expiry Date
Jan 30, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
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