Afinion™ HbA1c Control - Indonesia BPOM Medical Device Registration
Afinion™ HbA1c Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208420183. 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 ALERE HEALTH.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
AXIS-SHIELD DIAGNOSTICS, LTDCountry of Origin
United Kingdom
Authorized Representative
ALERE HEALTHAR Address
K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan
Registration Date
Jul 29, 2024
Expiry Date
Jan 15, 2029
Product Type
Hematological Reagents
Hematology quality control mixture.
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