careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag - Indonesia BPOM Medical Device Registration
careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303123634. The device is manufactured by WELLS BIO, INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOCORE PERKASA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
WELLS BIO, INC.Country of Origin
Korea
Authorized Representative
PT. INDOCORE PERKASAAR Address
Komplek Graha Mas Pemuda Blok AB No. 19, Jl. Pemuda RT 020 / RW 006 Kel. Jati, Kec. Pulo Gadung, Jakarta Timur, DKI Jakarta
Registration Date
Jun 21, 2021
Expiry Date
Dec 15, 2025
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
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