ANSWER One Step Syphilis Whole Blood/Serum/Plasma Test - Indonesia BPOM Medical Device Registration
ANSWER One Step Syphilis Whole Blood/Serum/Plasma Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420159. The device is manufactured by GUANGZHOU WONDFO BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EXXEL MAIN.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
GUANGZHOU WONDFO BIOTECH CO., LTDCountry of Origin
China
Authorized Representative
PT. EXXEL MAINAR Address
JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA
Registration Date
May 14, 2024
Expiry Date
Apr 28, 2027
Product Type
Serological Reagents
Treponema pallidum treponemal test reagents.
Invitro Diagnostics
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WONDFO cTnI/CK-MB/Myo Multi-Control
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WONDFO T3/T4/TSH Multi-Control
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ANSWER HCG Urine Test Strip
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WONDFO Coagulation Control
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ANSWER HCG Urine Test Cassette
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WONDFO MAU Control
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WONDFO CRP Control
GUANGZHOU WONDFO BIOTECH CO., LTD
WONDFO HbA1c Control
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WONDFO FIA Meter III Plus
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