AFIAS FSH - Indonesia BPOM Medical Device Registration
AFIAS FSH is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420545. The device is manufactured by BODITECH MED INC., from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is BODITECH MED INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BODITECH MED INC.,Country of Origin
Korea
Authorized Representative
BODITECH MED INDONESIAAR Address
Ruko Alam Sutera, Jalur Sutera Kavling 25 B-C No.1
Registration Date
Mar 27, 2024
Expiry Date
Oct 25, 2028
Product Type
Clinical Chemistry Test System
Follicle-stimulating hormone test system (strip & midstream)
Invitro Diagnostics
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AFIAS D-Dimer Neo
AFIAS Cyfra 21-1
AFIAS CRP
AFIAS NT-proBNP
AFIAS TSH
AFIAS PCT X
BODITECH RF IgM Control
BODITECH TSH Plus Control
AFIAS Vitamin D Neo
BODITECH D-Dimer Control
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AFIAS TSH PLUS
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SHARPENS CA19-9
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BODITECH Vitamin D Control
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AFIAS Total IgE
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Boditech Ferritin Control
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BODITECH Hormone Control
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AFIAS ST2
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BODITECH HbA1c Control
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BODITECH Tumor Marker Control
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