PROCLEIX Ultrio Elite Assay Discriminatory Probe Reagents - Indonesia BPOM Medical Device Registration
PROCLEIX Ultrio Elite Assay Discriminatory Probe Reagents is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305814261. The device is manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC. from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is MEDQUEST JAYA GLOBAL.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
GRIFOLS DIAGNOSTIC SOLUTIONS INC.Country of Origin
United States
Authorized Representative
MEDQUEST JAYA GLOBALAR Address
Menara Salemba Lantai 6 Jl. Salemba Raya Kav. 5 - 5A
Registration Date
Sep 23, 2022
Expiry Date
Sep 06, 2027
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
Procleix UltrioPlex E Assay Rehearsors Kit
Procleix UltrioPlex E Assay Target Enhancer Reagent Kit
PROCLEIX Ultrio Elite Assay Kit
PROCLEIX Auto Detect Reagents
GRIFOLS Procleix Ultrio Elite Assay Positive Calibrators
PROCLEIX Reagent Preparation Incubator 250 (RPI-250)
PROCLEIX Ultrio Elite Assay Target Enhancer Reagent
PROCLEIX HEV Assay and Accessories
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