CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo - Indonesia BPOM Medical Device Registration
CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303023552. 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
Registration Date
Nov 19, 2024
Expiry Date
Sep 23, 2029
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
careUS ™ Flu A&B Plus
CareGENE™ STD-12 Detection Kit
careGENE™ HPV Detection kit-M
careGENE™ HPV Screening kit-H
careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag
careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag
careSTART™ G6PD Biosensor Control Level II
careSTART™ G6PD Biosensor Control Level I
careSTART™ G6PD Biosensor Analyzer
careSTART™ G6PD Biosensor Strip
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