CITEST™ CEA Test Cassette (Serum/Plasma) - Indonesia BPOM Medical Device Registration
CITEST™ CEA Test Cassette (Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320310. The device is manufactured by CITEST DIAGNOSTICS INC from Canada, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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
Nelta Multi GraciaAR Address
Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960
Registration Date
Oct 10, 2023
Expiry Date
Feb 20, 2026
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
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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)
VIRCLIA AUXILIARY REAGENTS-EDB
VIRCELL S.L.
INVASIVE CANDIDIASIS (CAGTA) VIRCLIA IgG MONOTEST
VIRCELL S.L.
HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST
VIRCELL S.L
DIRECT SARS-COV-2 REAL TIME PCR KIT
VIRCELL SL
HELICOBACTER PYLORI VIRCLIA® IgG MONOTEST
VIRCELL S.L
HERPES SIMPLEX 1+2 VIRCLIA® IgG MONOTEST
VIRCELL S.L
HELICOBACTER PYLORI VIRCLIA® IgA MONOTEST
VIRCELL S.L
SERION ELISA Control Helicobacter pylori IgG
INSTITUT VIRION\SERION GMBH
SERION ELISA Control Aspergillus fumigatus IgG
INSTITUT VIRION\SERION GMBH
MEASLES VIRCLIA IgM MONOTEST
VIRCELL S.L

