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SD Bioline Dengue Duo (Dengue NS1Ag+Ab Combo) - Indonesia BPOM Medical Device Registration

SD Bioline Dengue Duo (Dengue NS1Ag+Ab Combo) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303214128. The device is manufactured by STANDARD DIAGNOSTICS, INC. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ALERE HEALTH.

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BPOM Registered
Risk Class Kelas Resiko : C
SD Bioline Dengue Duo (Dengue NS1Ag+Ab Combo)
Analysis ID: AKL 20303214128

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

PT. ALERE HEALTH

AR Address

K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan

Registration Date

Oct 31, 2022

Expiry Date

Jun 04, 2027

Product Type

Serological Reagents

Dengue virus serological reagents

Invitro Diagnostics

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