CITODIA Leptospira IgG/IgM Rapid Test Cassette - Indonesia BPOM Medical Device Registration
CITODIA Leptospira IgG/IgM Rapid Test Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303021793. The device is manufactured by ACRO BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PROSPEROUS BIOCARE.
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
ACRO BIOTECH, INC.Country of Origin
United States
Authorized Representative
PROSPEROUS BIOCAREAR Address
RUKO KRANGGAN PERMAI BLOK RT 017/30
Registration Date
Nov 23, 2023
Expiry Date
Jun 15, 2027
Product Type
Serological Reagents
Leptospira spp. serological reagents.
Invitro Diagnostics
ACRO Malaria P.f./P.v./Pan Rapid Test Cassette (Whole Blood)
ACRO Multi-Drug 10 Drugs Rapid Test Cup (Oral Fluid) (OPI40/MET50/COC20/AMP50/PCP10/BZO50/MTD30/MDMA50/CAR300/THC12)
ACRO Multi-Drug 10 Drugs Rapid Test Cup (Oral Fluid) (OPI40/MET50/COC20/AMP50/PCP10/BZO50/ MTD30/MDMA50/CAR300/THC12)
CITODIA Breath Alcohol Test
INStest ™ Influenza A/B and Respiratory Syncytial Virus RT-qPCR Kit
JUSCHEK Ecstasy (MDMA) Rapid Test Cassette
ACRO Malaria P.f./P.v. Rapid Test Cassette (Whole Blood)
ANSWER Multi-Drug Rapid Test 7 Panel (AMP, MOP, THC, COC, BZO, MET, CAR)
INSTEST™ Multi-Drug 3 Drugs Rapid Test Panel (AMP/MOP/THC)-(Urine)
INSTEST™ Multi-Drug 5 Drugs Rapid Test Panel (AMP/MOP/THC/MET/BZO)-(Urine)
DrAccu FSH FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu Testosterone FIA
ASSURE TECH. (HANGZHOU) CO., LTD.
DrAccu LH FIA
ASSURE TECH. (HANGZHOU) CO., LTD.
BIOER Fluorescent Quantitative Detection System
HANGZHOU BIOER TECHNOLOGY CO., LTD.
abTES™ DEN 4 qPCR II Kit
AITBIOTECH PTE., LTD.
ABTES™ Den/Chiku/Zika 3 qPCR I Kit
AITBIOTECH PTE., LTD.
abTES™ Malaria qPCR I Kit
AITBIOTECH PTE., LTD.
abTES™ Malaria 5 qPCR II Kit
AITBIOTECH PTE., LTD.
abGenix™ Automated DNA & RNA Extraction System
AITBIOTECH PTE., LTD.
NGenePlex™ nCoV qRT-PCR Kit
NGENEBIO CO., LTD