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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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BPOM Registered
Risk Class Kelas Resiko : B
careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag
Analysis ID: AKL 20303123634

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

WELLS BIO, INC.

Country of Origin

Korea

Authorized Representative

PT. INDOCORE PERKASA

AR 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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