ADVANCED TP Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) - Indonesia BPOM Medical Device Registration
ADVANCED TP Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303905627. The device is manufactured by INTEC PRODUCTS INC. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TRUE MITRASAMAYA.
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
INTEC PRODUCTS INC.Country of Origin
China
Authorized Representative
PT. TRUE MITRASAMAYAAR Address
RUKAN KENCANA NIAGA BLOK D1/2J
Registration Date
Aug 07, 2020
Expiry Date
Feb 11, 2025
Product Type
Serological Reagents
Treponema pallidum nontreponemal test reagents.
Invitro Diagnostics
ADVANCED QUALITY One Step Anti-HIV (1&2) Tri-Line Test Card
ADVANCED QUALITY ™ One Step Benzodiazepines (BZO) Test Card (Urine)
ADVANCED QUALITY™ One Step Barbiturates (BAR) Test Strip (Urine)
ADVANCED QUALITY Rapid HBsAg Test Card (Serum/Plasma/Whole Blood)
ADVANCED QUALITY Rapid HIV Test Card (Serum/Plasma/Whole Blood)
ADVANCED QUALITY Rapid Anti-HCV Test Strip (Serum/Plasma/Whole Blood)
ADVANCED QUALITY One Step HBsAb Test Card (Serum/Plasma)
ADVANCED QUALITY One Step Opiates (OPI/Morphines) Test Card (Urine)
ADVANCED QUALITY™ Rapid HBsAg Test Strip (Serum/Plasma/Whole Blood)
INTEC ABO & RhD Blood Grouping Kit (Solid-phase method)
ADVANCED QUALITY One Step Anti-HIV (1&2) Test Strip ( WholeBlood/Serum/Plasma)
INTEC PRODUCT., INC
LIBO Low Ionic Salt Solution
JIANGSU LIBO MEDICINE BIOTECHNOLOGY CO., LTD.
ADVANCED QUALITY One Step Anti-HIV (1&2) Tri-Line Test Card
INTEC PRODUCTS INC.
Blood Bank Refrigerator KXC - 1100 G
QINGDAO CAREBIOS BIOLOGICAL TECHNOLOGY CO., LTD
CAREBIOS Blood Bank Refrigerator KXC-600 G
QINGDAO CAREBIOS BIOLOGICAL TECHNOLOGY CO., LTD
ADVANCED QUALITY One Step Cocaine (COC) Test Strip (Urine )
INTEC PRODUCTS., INC.
INTEC ABO & RhD Blood Grouping Kit Test Strip (Solid - Phase Method) Versi 2.0
INTEC PRODUCTS , INC
ADVANCED QUALITY™ One Step Cannabinoids (THC) Test Strip (Urine)
INTEC PRODUCTS., P.R.
INTEC One Step Cocaine (COC) Test Card (Urine)
INTEC PRODUCTS INC.,P.R
inTec ABO & RhD Blood Grouping Kit Test Card ( Solid - Phase Method) versi 2.0
INTEC PRODUCTS , INC