NeuMoDx™ HIV-1 Calibrators - Indonesia BPOM Medical Device Registration
NeuMoDx™ HIV-1 Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220197. 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 INODIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
NEUMODX MOLECULAR, INC.Country of Origin
United States
Authorized Representative
INODIAAR Address
Perkantoran Kedoya Elok Plaza Blok DB no 24, Jalan Panjang, Kebon Jeruk
Registration Date
Jun 03, 2022
Expiry Date
Oct 08, 2025
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
NeuMoDx 96 Molecular System
NeuMoDx™ 288 Molecular System
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™ HBV Calibrators
NeuMoDx™ TV/MG Test Strip
NeuMoDx™ HBV External Controls
QIAsymphony SP + Accessories
ZOLLNER ELECTRONICS GMBH
QIAsymphony AS and Accessories
HAMILTON BONADUZ AG.
QIASYMPHONY DSP Virus/Pathogen Midi Kit
QIAGEN GMBH.
THERASCREEN RAS Extension Pyro Kit and Accessories
QIAGEN GMBH
THERASCREEN KRAS RGQ PCR Kit
QIAGEN GMBH.
IPSOGEN ® BCR-ABL1 Mbcr RGQ RT-PCR Kit
QIAGEN GMBH.
EasyNAT® Safety Sputum Container
USTAR BIOTECHNOLOGIES (HANGZHOU) LTD
NeuMoDx™ SARS-CoV-2 Test Strip
NEUMODX MOLECULAR, INC.
QIAcube Connect MDx + accessories
ZOLLNER ELEKTRONIK AG
EasyNAT® Nucleic Acid Amplification and Detection Analyzer UC0104
USTAR BIOTECHNOLOGIES (HANGZHOU) LTD