SANSURE MTB/NTM/MDR-TB Nucleic Acid Diagnostic Kit (Fluorescent PCR-Melting Curve Method) - Indonesia BPOM Medical Device Registration
SANSURE MTB/NTM/MDR-TB Nucleic Acid Diagnostic Kit (Fluorescent PCR-Melting Curve Method) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303520096. The device is manufactured by SANSURE BIOTECH INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SANSURE BIOTECH INDONESIA.
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
SANSURE BIOTECH INC.Country of Origin
China
Authorized Representative
PT. SANSURE BIOTECH INDONESIAAR Address
RUKO GARDEN SHOPPING ARCADE (GSA), UNIT B/09/BP, KOMPLEK PODOMORO CITY, JALAN S. PARMAN KAVELING 28
Registration Date
Feb 05, 2025
Expiry Date
Mar 05, 2029
Product Type
Serological Reagents
Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens (kit & cair)
Invitro Diagnostics
SANSURE Sample Diluent
SANSURE Urine Sample Collector
SANSURE Sample Storage Reagent
SANSURE Hepatitis B Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)
SANSURE Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)
SANSURE Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing)
SANSURE Novel Coronavirus (2019-nCoV) nucleic Acid Diagnostic Kit (PCR-Fluorescence)
SANSURE Nucleic Acid Extraction System
SANSURE Nucleic Acid Extraction System, NATCH S-F11B System
SANSURE NATCH S-F11C System
SANSURE Sample Diluent
SANSURE BIOTECH INC.
IPONATIC Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
SANSURE BIOTECH INC
SANSURE Urine Sample Collector
SANSURE BIOTECH INC.
SANSURE Hepatitis B Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)
SANSURE BIOTECH INC.
SANSURE Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)
SANSURE BIOTECH INC.
SANSURE Novel Coronavirus (2019-nCoV) nucleic Acid Diagnostic Kit (PCR-Fluorescence)
SANSURE BIOTECH INC.
SANSURE Nucleic Acid Extraction System
SANSURE BIOTECH INC.
SANSURE Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)
SANSURE BIOTECH INC.
SANSURE Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method)
SANSURE BIOTECH INC.
SANSURE Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)
SANSURE BIOTECH INC.