CITEST™ Fluorescence Immunoassay Analyzer - Indonesia BPOM Medical Device Registration
CITEST™ Fluorescence Immunoassay Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304220122. The device is manufactured by CITEST DIAGNOSTICS INC from Canada, 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
CITEST DIAGNOSTICS INCCountry of Origin
Canada
Authorized Representative
PT. NELTA MULTI GRACIAAR Address
Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960
Registration Date
Jan 23, 2025
Expiry Date
Feb 20, 2026
Product Type
Immunology Laboratory Equipment and Reagents
Immunofluorometer equipment
Invitro Diagnostics
CITEST ™ D-Dimer Test Cassette (Whole Blood/Plasma)
CITEST - Multi-Drug 3 Drugs Rapid Test Cassette (Urine) (MOP300/AMP1000/THC50)
CITEST Multi-Drug 6 Drugs Rapid Test Panel (Urine) (MOP300/COC300/AMP1000/MET1000/THC50/BZO300)
CITEST™ T3 Test Cassette (Serum/Plasma)
TSH Test Cassette (Serum/Plasma)
CITEST™ T4 Test Cassette (Serum/Plasma)
PLATINUM Influenza A+B Rapid Test Cassette (Swab/Nasal Aspirate)
CITEST Malaria P.f./P.v./Pan Test Cassette (Whole Blood)
PLATINUM Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)
CITEST ™ FSH Test Cassette (Whole Blood/Serum/Plasma)
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 ™ Insulin (INS) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
UNVEIL ™ Serum Amyloid A Protein (SAA) Test Kit (CLIA)
HANGZHOU ALLTEST BIOTECH CO., LTD.
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.
VIRCLIA AUXILIARY REAGENTS-EDP
VIRCELL S.L

