ACRO Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration
ACRO Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303911164. The device is manufactured by HANGZHOU ALLTEST BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is RAFA TOPAZ MAIN.
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
RAFA TOPAZ MAINAR Address
Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur
Registration Date
Apr 06, 2022
Expiry Date
Aug 19, 2026
Product Type
Serological Reagents
Plasmodium species antigen detection assays
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
LORNE Salmonella Typhi O
LORNE LABORATORIES LIMITED
LORNE IM Latex Test Kit
LORNE LABORATORIES.
LORNE Salmonella Typhi H
LORNE LABORATORIES LIMITED
LORNE CRP Latex Test Kit
LORNE LABORATORIES LIMITED
LORNE Salmonella Paratyphi AH
LORNE LABORATORIES LIMITED
LORNE Salmonella Paratyphi CH
LORNE LABORATORIES LIMITED.
LORNE Salmonella Paratyphi CO
LORNE LABORATORIES LIMITED.
LORNE Salmonella Paratyphi BH
LORNE LABORATORIES LIMITED.
LORNE Salmonella Paratyphi BO
LORNE LABORATORIES LIMITED.
LORNE Salmonella Paratyphi AO
LORNE LABORATORIES LIMITED