STAR DIAGNOSTICS Syphilis Rapid Test Cassette - Indonesia BPOM Medical Device Registration
STAR DIAGNOSTICS Syphilis Rapid Test Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321316. The device is manufactured by HANGZHOU ALLTEST BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. LANIROS DIAN PHARMA.
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
HANGZHOU ALLTEST BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. LANIROS DIAN PHARMAAR Address
GEDUNG SATRIO TOWER LT. 22, JL. PROF. DR. SATRIO KAV. C4
Registration Date
Aug 09, 2023
Expiry Date
Aug 07, 2026
Product Type
Serological Reagents
Treponema pallidum nontreponemal test reagents.
Invitro Diagnostics
UNVEIL™ 25 OH Vitamin D (25-OH VD) Test Kit (CLIA)
UNVEIL ™ Procalcitonin (PCT) Test Kit (CLIA)
ALLCALL Uric Acid Test Strip
UNVEIL™ Glycated Hemoglobin (HbA1c) Test Kit (CLIA)
UNVEIL ™ Insulin (INS) Test Kit (CLIA)
UNVEIL ™ Serum Amyloid A Protein (SAA) Test Kit (CLIA)
OPTIMUS Test Syphilis Serum One Step Diagnostic Rapid Test (Cassette)
OPTIMUS Test Tuberculosis (TB) Serum One Step Diagnostic Rapid Test (Cassette)
ALLCALL Blood Glucose/Ketone/Uric Acid/Total Cholesterol 4 in 1 Monitoring System I
AIM Rapid Test Ferritin-F
Woman Choice+ Early Detection Pregnancy Test Midstream
ARTRON LABORATORIES INC.
Woman Choice+ Early Detection Pregnancy Test Strip
ARTRON LABORATORIES INC.
CLIMAX Multitexture Condom
MHL HEALTHCARE LIMITED
CLIMAX Plain Condom
MHL HEALTHCARE LIMITED
SENSOR Multi-Drug 10 Drugs Rapid Test Panel (THC50/MOP300/AMP1000/MET500/COC300/BZO300/K2/ETG/CAR/PCP)
HANGZHOU ALLTEST BIOTECH CO., LTD.
SENSOR Multi-Drug 6 Drugs Rapid Test Panel (THC50/AMP1000/MET500/BZO300/COC300/MOP300)
HANGZHOU ALLTEST BIOTECH CO., LTD.
SENSOR Multi-Drug 7 Drugs Rapid Test Panel (THC50/MOP300/AMP1000/MET500/COC300/BZO300/CAR)
HANGZHOU ALLTEST BIOTECH CO., LTD.
STAR DIAGNOSTIC PLUS HBsAg Strip Test
ARTRON LABORATORIES INC.
STAR DIAGNOSTICS Dengue IgG/IgM Rapid Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.
STAR DIAGNOSTICS Malaria P.f./P.v. Rapid Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.