VITROS Immunodiagnostic Products Anti-HCV Controls - Indonesia BPOM Medical Device Registration

VITROS Immunodiagnostic Products Anti-HCV Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305021706. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is EMERALINDO ASIA PACIFIC.

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BPOM Registered

Risk Class Kelas Resiko : B

VITROS Immunodiagnostic Products Anti-HCV Controls

Analysis ID: AKL 20305021706

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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

Mar 24, 2024

Expiry Date

Feb 24, 2028

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack

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ORTHO Anti-IgG/Anti-C3b, -C3d/Control Ortho BioVue System (DAT/IDAT Cassette)

Kelas Resiko : B

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Kelas Resiko : B

ORTHO Reverse Diluent Ortho BioVue ® System (Reverse Diluent Cassette)

Kelas Resiko : C

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Kelas Resiko : C

ORTHO Blood Grouping Reagents Anti-A/Anti-B/Anti-D Control /Reverse Diluent Ortho BioVue System (ABO-Rh/Reverse Grouping Cassette)

Kelas Resiko : C

VITROS Immunodiagnostic Products System Cleaning Solution

Kelas Resiko : A

VITROS Immunodiagnostic Products Rubella IgM Reagent Pack

Kelas Resiko : C

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack

Kelas Resiko : D

VITROS Immunodiagnostic Products Rubella IgM Calibrator

Kelas Resiko : C

Other Products from EMERALINDO ASIA PACIFIC

Products with the same authorized representative (10 products)

VITROS Chemistry Products wrCRP Reagent

SENTINEL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products System Cleaning Solution

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Kelas Resiko : A

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : D

VITROS Immunodiagnostic Products Rubella IgM Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : C

VITROS Immunodiagnostic Products Rubella IgM Calibrator

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : C

VITROS Immunodiagnostic Products Free PSA Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : C

VITROS Immunodiagnostic Products Total T3 Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products LH Calibrators

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products HBeAg Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : D

VITROS Immunodiagnostic Products Testosterone Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B