PRIMELINE Bilirubin Direct, DCA - Indonesia BPOM Medical Device Registration
PRIMELINE Bilirubin Direct, DCA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221203. The device is manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MULTI SARANA MEDIKA.
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
BEIJING STRONG BIOTECHNOLOGIES, INCCountry of Origin
China
Authorized Representative
PT. MULTI SARANA MEDIKAAR Address
Komp. Gading Bukit Indah Jl. Bukit Gading Raya Blok B Kav. No.1
Registration Date
Aug 12, 2022
Expiry Date
Aug 09, 2025
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
PRIMELINE Multicalibrator
PRIMELINE Adenosine Deaminase Assay Kit (ADA)
PRIMELINE Albumin, BCG
PRIMELINE GPT/ALT
PRIMELINE Alkaline Phosphatase
PRIMELINE Urea, Urease/GLDH
PRIMELINE Creatinine, Enzymatic
PRIMELINE LDL Cholesterol Direct, Surfactant clearance
PRIMELINE HDL Cholesterol Direct, Select inhibition
PRIMELINE GOT/AST
PRIMELINE PLc Calibration Standard Solution
MEIZHOU CORNLEY HI-TECH CO., LTD.
BIOTECNICA BT 4500
BIOTECNICA INSTRUMENTS SPA.
PRIMELINE Electrolyte Analyzer PL c402 and Accessories
B&E BIO-TECHNOLOGY CO., LTD.
BIOTECNICA BT 1500 and Accessories
BIOTECNICA INSTRUMENTS SPA.
PRIMELINE PL c305-ts Electrolyte Analyzer and Accessories
MEIZHOU CORNLEY HI-TECH CO., LTD.
PRIMELINE PLc Calibration Standard Solution
MEIZHOU CORNLEY HI-TECH CO., LTD.
FIATESTโข Fecal Occult Blood Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.
FIATESTโข CEA Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.
FIATESTโข Dengue IgG/IgM Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.
PRIMELINE Multicalibrator
BEIJING STRONG BIOTECHNOLOGIES, INC

