ORTHO SURGISCREEN - Indonesia BPOM Medical Device Registration
ORTHO SURGISCREEN is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209420284. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. DIASTIKA BIOTEKINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS, INCCountry of Origin
United States
Authorized Representative
PT. DIASTIKA BIOTEKINDOAR Address
Rukan Sentra Pemuda Kav.30 - 31 Jalan Pemuda No.61 RT.009 RW.003 Kel. Rawamangun Kec.Pulogadung
Registration Date
Dec 30, 2024
Expiry Date
Feb 15, 2027
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated blood grouping and antibody test system.
Invitro Diagnostics
ORTHO™ 7% BSA Reagent
VITROS Immunodiagnostic Products Universal Wash Reagent
VITROS Chemistry Products Immuno-Wash Fluid
VITROS Chemistry Products A1c Slides
VITROS Chemistry Products hsCRP Performance Verifier I
VITROS Chemistry Products hsCRP Reagent
VITROS Chemistry Products hsCRP Performance Verifier III
VITROS Chemistry Products Calibrator Kit 33
VITROS Chemistry Products hsCRP Performance Verifier II
VITROS Chemistry Products Calibrator Kit 17
METER TRAX Control Low
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METER TRAX™ Control Mid
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BIO-RAD METER TRAX Control High
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Liquichek™ Homocysteine Control Level 1
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BIO-RAD Liquichek™ Homocysteine Control Level 3
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ORTHO 0.8% SURGISCREEN
ORTHO-CLINICAL DIAGNOSTICS INC.,
MGI Universal Sequencing Reaction Kit
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MGI Universal Sequencing Reaction Kit
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MP Diagnostics HIV BLOT 2.2 Western Blot Assay
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ORTHO Anti-IgG/Anti-C3b, -C3d/Control Ortho BioVue System (DAT/IDAT Cassette)
ORTHO-CLINICAL DIAGNOSTICS