OPTICAL Q beta-hCG - Indonesia BPOM Medical Device Registration
OPTICAL Q beta-hCG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322785. The device is manufactured by OPTIBIO.CO.,LTD from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KIRANA JAYA LESTARI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
OPTIBIO.CO.,LTDCountry of Origin
Korea
Authorized Representative
PT. KIRANA JAYA LESTARIAR Address
JL. TANAH ABANG II NO. 37
Registration Date
Mar 15, 2023
Expiry Date
Mar 02, 2027
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (card)
Invitro Diagnostics
OPTICAL Q D-Dimer
Optical Q CEA
OPTICAL Q PRL
OPTICAL Q Ferritin
OPTICAL Q FSH
OPTICAL Q Total T3
OPTICAL Q Free T4
Optical Q TSH
OPTICAL Q HbA1c
Optical Q™ CRP
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