ADVIA Chemistry Enzymatic Hemoglobin A1c_E Assay - Indonesia BPOM Medical Device Registration
ADVIA Chemistry Enzymatic Hemoglobin A1c_E Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207220037. The device is manufactured by SEKISUI MEDICAL CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SEKISUI MEDICAL CO., LTD.Country of Origin
Japan
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta
Registration Date
Mar 08, 2022
Expiry Date
Mar 04, 2025
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
BM Test HbA1c Control (High dan Low)
BM Test HbA1c Diluent
SEKISUI Glycated Albumin Control
NORUDIA GA
SEKISUI Cystatin C Control N
SEKISUI Cystatin C Calibrator N
NORUDIA GA Calibrator
SEKISUI L-FABP Control
NORUDIA L-FABP Calibrator
NORUDIA L- FABP
ADVIA Centaur Calibrator D
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