SERION ELISA Agile SARS-CoV-2 IgM - Indonesia BPOM Medical Device Registration
SERION ELISA Agile SARS-CoV-2 IgM is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303122896. The device is manufactured by INSTITUT VIRION\SERION GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NELTA MULTI GRACIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
INSTITUT VIRION\SERION GMBHCountry of Origin
Germany
Authorized Representative
PT. NELTA MULTI GRACIAAR Address
Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960
Registration Date
Dec 20, 2022
Expiry Date
Feb 21, 2026
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
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SERION ELISA classic Brucella IgA
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