Optical Q CEA - Indonesia BPOM Medical Device Registration
Optical Q CEA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320267. The device is manufactured by OPTIBIO.CO.,LTD from Korea, Democratic People's Republic Of, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is KIRANA JAYA LESTARI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
OPTIBIO.CO.,LTDCountry of Origin
Korea, Democratic People's Republic Of
Authorized Representative
KIRANA JAYA LESTARIAR Address
Jl. Tanah Abang II No. 37 RT.001/RW.003, Kode Pos 10160, Kel. Petojo Selatan, Kec. Gambir, Kota Jakarta Pusat, Provinsi DKI Jakarta
Registration Date
Aug 09, 2023
Expiry Date
Mar 02, 2027
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
OPTICAL Q D-Dimer
OPTICAL Q Ferritin
OPTICAL Q PRL
OPTICAL Q FSH
OPTICAL Q beta-hCG
OPTICAL Q HbA1c
OPTICAL Q Total T3
OPTICAL Q Free T4
Optical Q TSH
OPTICAL Q Fluorimetric Immunoassay Analyzer
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