SERION ELISA classic Respiratory Syncytial Virus (RSV) IgM - Indonesia BPOM Medical Device Registration
SERION ELISA classic Respiratory Syncytial Virus (RSV) IgM is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303810807. 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.
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
INSTITUT VIRION\SERION GMBH.Country 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
Nov 23, 2022
Expiry Date
Feb 21, 2026
Product Type
Serological Reagents
Respiratory syncytial virus serological reagents.
Invitro Diagnostics
SERION RF Absorbent
SERION ELISA classic Mycoplasma Pneumoniae IgG
SERION ELISA classic Toxoplasma gondii IgG
SERION ELISA classic Brucella IgM
SERION ELISA classic MASERN VIRUS/MEASLES/REUGEOLE IgM
SERION ELISA classic Masern Virus/Measles/Rougeole IgG
SERION ELISA Classic Leptospira IgG
SERION ELISA classic Respiratory Syncytial Virus (RSV) IgG
SERION ELISA classic Bordetella Pertussis IgG
SERION ELISA classic Helicobacter pylori IgG
UNVEIL™ 25 OH Vitamin D (25-OH VD) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
UNVEIL ™ Procalcitonin (PCT) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
UNVEIL™ Glycated Hemoglobin (HbA1c) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
UNVEIL ™ Serum Amyloid A Protein (SAA) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
UNVEIL ™ Insulin (INS) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
CITEST™ Fluorescence Immunoassay Analyzer
CITEST DIAGNOSTICS INC
UNVEIL™ D-Dimer Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
UNVEIL ™ Ferritin Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
STAT Fax 4700 Microstrip Reader and Accessories
AWARENESS TECHNOLOGY, INC
UNVEIL™ C-reactive Protein (CRP) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.