ATELLICA IM Squamous Cell Carcinoma Calibrator (SCC CAL) - Indonesia BPOM Medical Device Registration
ATELLICA IM Squamous Cell Carcinoma Calibrator (SCC CAL) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320255. The device is manufactured by FUJIREBIO EUROPE N.V. from Belgium, 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
FUJIREBIO EUROPE N.V.Country of Origin
Belgium
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Jul 25, 2023
Expiry Date
Mar 04, 2025
Product Type
Tumor Antigen Immunologic Test System
Immunomagnetic circulating cancer cell selection and enumeration system.
Invitro Diagnostics
INNO-LiPA HPV Genotyping Extra II <20T,CE>
INNO-LiPA HPV Genotyping Extra II Amp <20T, CE>
INNO-LIA HIV I/II Score
INNOTEST PHOSPHO-TAU (181P)
INNOTEST ฮฒ-AMYLOID(1-40)
INNO-LIA HCV Score
INNOTEST ฮฒ-AMYLOID(1-42)
INNOTEST hTau Ag
Tendigo
LiRAS for LiPA HPV v3
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