CELL-DYN Reticulocyte Reagent (CELL-DYN Sapphire Systems) - Indonesia BPOM Medical Device Registration
CELL-DYN Reticulocyte Reagent (CELL-DYN Sapphire Systems) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10201220272. The device is manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INCCountry of Origin
United States
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Aug 26, 2022
Expiry Date
Feb 10, 2027
Product Type
Biological Dyes
Dye and chemical solution stains.
Invitro Diagnostics
ALINITY c ICT Serum Calibrator Kit
ALINITY c Creatine Kinase Reagent Kit
ALINITY c Urine / CSF Protein Reagent Kit
ALINITY i Anti-TPO Controls
ALINITY i Anti TPO Calibrators
ALINITY i B.R.A.H.M.S PCT Controls
ALINITY i B.R.A.H.M.S PCT Calibrators
ALINITY i Anti-Tg Controls
CELL-DYN Ruby Systems WBC Lyse
CELL-DYN Sapphire Systems CN-FREE HGB Reagent
ARCHITECT Estradiol Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ARMADA 35 PTA Catheter
ABBOTT VASCULAR COSTA RICA
ARCHITECT PIVKA-II Controls
DENKA CO., LTD.
ARCHITECT PIVKA-II Reagent Kit
DENKA CO., LTD.
ALINITY i PIVKA-II Controls
DENKA CO., LTD.
ALINITY i PIVKA-II Calibrators
DENKA CO., LTD.
XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System
ABBOTT VASCULAR
ALINITY c Calcium2
ABBOTT IRELAND DIAGNOSTICS DIVISION
HI-TORQUE Command 18 LT Guide Wire
ABBOTT VASCULAR
ARCHITECT BNP Controls
FUJIREBIO DIAGNOSTICS, INC.

