VITROS Immunodiagnostic Products HBsAg ES Confirmatory Kit - Indonesia BPOM Medical Device Registration

VITROS Immunodiagnostic Products HBsAg ES Confirmatory Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305420055. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS from United Kingdom, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is EMERALINDO ASIA PACIFIC.

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BPOM Registered

Risk Class Kelas Resiko : D

VITROS Immunodiagnostic Products HBsAg ES Confirmatory Kit

Analysis ID: AKL 30305420055

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS

Country of Origin

United Kingdom

Authorized Representative

EMERALINDO ASIA PACIFIC

AR Address

RUKAN PERMATA SENAYAN BLOK G15, Lantai 1, JL.TENTARA PELAJAR NO. 5, Desa/Kelurahan Grogol Utara, Kec. Kebayoran Lama, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta Kode Pos: 12210

Registration Date

Feb 06, 2024

Expiry Date

Feb 24, 2028

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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