MOLECISION™ Nucleic Acid Extraction Kit - Indonesia BPOM Medical Device Registration
MOLECISION™ Nucleic Acid Extraction Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204127136. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. NUSANTARA BINA DIAGNOSTIKA.
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 : 1
Country of Origin
China
Authorized Representative
PT. NUSANTARA BINA DIAGNOSTIKAAR Address
Pertokoan Bali View No. 35 Jl. Rajawali Pisangan Ciputat, Tangerang Selatan
Registration Date
Nov 19, 2021
Expiry Date
Dec 31, 2023
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
MAGLUMI Digoxin (CLIA)
Biossays Creatine kinase-MB isozyme Assay Kit (Immunosuppression)
Biossays Assayed Chemistry Quality Control
BIOSSAYS ISE-REAGENT PACK
BIOSSAYS Alkaline Wash
BIOSSAYS Assayed Chemistry Calibrators
BIOSSAYS Alkaline phospatase Assay Kit (IFCC)
BIOSSAYS™ ALT Alanine Aminotransferase Assay Kit (IFCC)
MOLECISION™ SARS-CoV-2 RT-PCR Assay
RADI PREP PLUS Swab and Stool DNA/RNA KIT
KH MEDICAL CO.,LTD.
RADI PREP Swab and Stool DNA/RNA KIT
KH MEDICAL CO.,LTD.
RADI PREP PLUS
KH MEDICAL CO.,LTD.
REALY TECH ™ High Sensitivity C-Reactive Protein (hsCRP) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH™ Herpes Simplex Virus -1/2 IgG (HSV-1/2 IgG) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH™ D-Dimer (DD) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH ™ Total Immunoglobulin E (Total IgE) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH™ 25-Hydroxy Vitamin D (25-OH VD) Assay Reagent Kit(CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH ™ Anti-Mullerian Hormone (AMH) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH ™ Procalcitonin (PCT) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.

