Alinity c-series Maintenance Solution - Indonesia BPOM Medical Device Registration
Alinity c-series Maintenance Solution is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204121920. The device is manufactured by SEKISUI DIAGNOSTICS P.E.I. INC. from Canada, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.Country of Origin
Canada
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Jan 24, 2023
Expiry Date
Dec 16, 2025
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
ALINITY c ICT Urine Calibrator Kit
ALINITY c Hemoglobin A1c Reagent Kit
ALINITY c Hemoglobin A1c Controls
ALINITY c Hemoglobin A1c Calibrators
ALINITY c Glucose Reagent Kit
Lipase Calibrator
ARCHITECT Direct LDL
ABBOTT Alanine Aminotransferase For Use With Architect
ALINITY c Direct LDL Reagent Kit
ABX Pentra Enzymatic Creatinine CP
ALINITY c Lactate Dehydrogenase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Total T4 Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ALINITY c Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Consolidated Chemistry Calibrator
RANDOX LABORATORIES, LTD
ARCHITECT Total T4 Controls
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 NTW Clip Delivery System
ABBOTT MEDICAL (MENLO PARK)
ABBOTT Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 Steerable Guide Catheter
ABBOTT MEDICAL. (Menlo park)
CELL-DYN Emerald 22 Diluent
AVANTOR PERFORMANCE MATERIALS S.A.
ALINITY hs Slide Maker Stainer Module and Accessories
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD