NeuMoDx™ HBV Calibrators - Indonesia BPOM Medical Device Registration
NeuMoDx™ HBV Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305126304. The device is manufactured by NEUMODX MOLECULAR, INC. from United States, 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
NEUMODX MOLECULAR, INC.Country of Origin
United States
Authorized Representative
PT. INODIAAR Address
Perkantoran Kedoya Elok Plaza Blok DB no 24, Jalan Panjang, Kebon Jeruk
Registration Date
Oct 25, 2021
Expiry Date
Oct 08, 2025
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
Invitro Diagnostics
NeuMoDx 96 Molecular System
NeuMoDx™ 288 Molecular System
NeuMoDx™ HIV-1 Calibrators
NeuMoDx™ HIV-1 External Controls
NeuMoDx™ SARS-CoV-2 Test Strip
NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip
NeuMoDx™ Saliva Collection Kit
NeuMoDx™ HCV Quant Test Strip
NeuMoDx™ TV/MG Test Strip
NeuMoDx™ HBV External Controls
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