ARCHITECT HBeAg Quantitative Calibrators - Indonesia BPOM Medical Device Registration
ARCHITECT HBeAg Quantitative Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305615944. The device is manufactured by ABBOTT GMBH. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ABBOTT GMBH.Country of Origin
Germany
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
Apr 04, 2024
Expiry Date
Jan 09, 2029
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
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