VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water) - Indonesia BPOM Medical Device Registration
VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320579. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is EMERALINDO ASIA PACIFIC.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS INC.Country of Origin
United States
Authorized Representative
EMERALINDO ASIA PACIFICAR Address
Rukan Permata Senayan Blok G 15, Jl. Tentara Pelajar Rt/Rw 009/007, Kel. Grogol Utara Kec. Kebayoran Lama, Jakarta Selatan 12210
Registration Date
May 30, 2023
Expiry Date
Feb 24, 2028
Product Type
Hematological Reagents
Blood cell diluents
Invitro Diagnostics
ORTHO 0.8% Red Cell Diluent
VITROS Chemistry Products Liquid performance Verifier I
VITROS Chemistry Products Liquid Performance Verifier II
VITROS Chemistry Products mALB Performance Verifier I
VITROS Chemistry Products Calibrator Kit 29
VITROS Chemistry Products % A1c Performance Verifier II
VITROS Chemistry Products BuBc Slides
VITROS Chemistry Products ALC Slides
VITROS Chemistry Products TDM Performance Verifier II
VITROS Chemistry Products CKMB Slides
VITROS Chemistry Products wrCRP Reagent
SENTINEL DIAGNOSTICS
VITROS Immunodiagnostic Products System Cleaning Solution
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Rubella IgM Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Rubella IgM Calibrator
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Free PSA Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Total T3 Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products LH Calibrators
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products HBeAg Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Testosterone Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS