BECKMAN COULTER Access Active B12 - Indonesia BPOM Medical Device Registration
BECKMAN COULTER Access Active B12 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221911. 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 DHH TRADING INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
AXIS-SHIELD DIAGNOSTICS LTDCountry of Origin
United Kingdom
Authorized Representative
DHH TRADING INDONESIAAR Address
Gedung World Trade Center 3, Lt. 20, Jl. Jend. Sudirman Kav. 29-31, Kel. Karet, Kec. Setiabudi, Jakarta Selatan, DKI Jakarta
Registration Date
Nov 16, 2022
Expiry Date
Feb 10, 2026
Product Type
Clinical Chemistry Test System
Vitamin B12 test system (kit & cair)
Invitro Diagnostics
ADVIA Centaur IL-6 QC
BECKMAN COULTER ACCESS Active B12 QC
BECKMAN COULTER Access Active B12 Calibrators
Atellica IM Interleukin-6 (IL6) Ready Pack
ATELLICA IM aCCP QC
Atellica IM Anti-CCP (aCCP)
ADVIA Centaur IL-6
iQ Calibrator
BECKMAN COULTER, INC.
Iris Diluent Pack
BECKMAN COULTER INC.
BECKMAN COULTER DxU 810c Iris Urine Chemistry Analyzer
BECKMAN COULTER, INC
INFINITY Lithium Reagent for Beckman Coulter AU Chemistry Analyzers
FISHER DIAGNOSTICS
G6PD Control Intermediate
SENTINEL CH. S.P.A
G6PD Control Normal
SENTINEL CH. S.P.A
COULTER TruColor Wright Stain Buffer
POLYSCIENCES INC.
COULTER TruColor Wright Stain
POLYSCIENCES INC.
Access HIV combo V2 QC
BIO-RAD
BECKMAN COULTER Digoxin
MICROGENICS CORPORATION