CELL-DYN Diluent/Sheath (CELL-DYN Sapphire and CELL-DYN Ruby Systems) - Indonesia BPOM Medical Device Registration
CELL-DYN 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 20208220211. The device is manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC. 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
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.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
Sep 01, 2022
Expiry Date
Feb 10, 2027
Product Type
Hematological Reagents
Blood cell diluents
Invitro Diagnostics
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