CHOLESTECH LDX ™ Multianalyte Control - Indonesia BPOM Medical Device Registration
CHOLESTECH LDX ™ Multianalyte Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101222035. The device is manufactured by AXIS-SHIELD DIAGNOSTICS, LTD from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ALERE HEALTH.
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
AXIS-SHIELD DIAGNOSTICS, LTDCountry of Origin
United Kingdom
Authorized Representative
PT. ALERE HEALTHAR Address
K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan
Registration Date
Dec 13, 2023
Expiry Date
Jun 04, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
ALERE NT-proBNP for Alinity i Calibrators
ALERE NT-proBNP for ARCHITECT Calibrator Packs
ALERE NT-proBNP for ARCHITECT Reagent Packs
Afinion™ HbA1c Control
CHOLESTECH LDX ™ Calibration Verification
ALERE NT-proBNP for Alinity Reagent Packs
DETERMINE HBsAg 2
ABBOTT DIAGNOSTICS MEDICAL CO., LTD.
Bioline™ HCV
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE Salmonella Typhi IgG/IgM Fast
ABBOTT DIAGNOSTICS KOREA INC
AFINION™ Lipid Panel Control
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
DETERMINE™ HIV Early Detect
ABBOTT DIAGNOSTICS MEDICAL CO., LTD
BIOLINE™ Dengue NS1 Ag
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE™ Rotavirus
ABBOTT DIAGNOSTICS KOREA INC
AFINION™ Lipid Panel
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
BIOLINE™ Dengue Duo
ABBOTT DIAGNOSTICS KOREA INC
ALERE NT-proBNP for Alinity i Controls
AXIS-SHIELD DIAGNOSTICS, LTD.

