VITROS Immunodiagnostic Products NTx Controls - Indonesia BPOM Medical Device Registration

VITROS Immunodiagnostic Products NTx Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420064. 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 NTx Controls

Analysis ID: AKL 20101420064

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

Jan 17, 2024

Expiry Date

Feb 24, 2028

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Products from the same manufacturer (10 products)

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

ORTHO Anti-Human Globulin Anti-lgG (Rabbit) (Green) Ortho BioVue System (IgG Cassette)

Kelas Resiko : B

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

Kelas Resiko : C

VITROS Immunodiagnostic Products Free PSA Calibrators

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