ABBOTT Diluent / Sheath (Cell-Dyn Sapphire and Cell-Dyn Ruby Systems - Indonesia BPOM Medical Device Registration
ABBOTT Diluent / Sheath (Cell-Dyn Sapphire and Cell-Dyn Ruby Systems is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208901475. The device is manufactured by ABBOTT LABORATORIES. from United States, 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 LABORATORIES.Country of Origin
United States
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
Dec 19, 2024
Expiry Date
Jun 04, 2026
Product Type
Hematological Reagents
Blood cell diluents
Invitro Diagnostics
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