PROCLEIX Auto Detect Reagents - Indonesia BPOM Medical Device Registration
PROCLEIX Auto Detect Reagents is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204814738. The device is manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC. from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MEDQUEST JAYA GLOBAL.
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 : 1
Manufacturer
GRIFOLS DIAGNOSTIC SOLUTIONS INC.Country of Origin
United States
Authorized Representative
PT. MEDQUEST JAYA GLOBALAR Address
Menara Salemba Lantai 6 Jl. Salemba Raya Kav. 5 - 5A
Registration Date
Sep 15, 2022
Expiry Date
Sep 06, 2027
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
Procleix UltrioPlex E Assay Rehearsors Kit
Procleix UltrioPlex E Assay Target Enhancer Reagent Kit
PROCLEIX Ultrio Elite Assay Kit
PROCLEIX Ultrio Elite Assay Discriminatory Probe Reagents
PROCLEIX Reagent Preparation Incubator 250 (RPI-250)
GRIFOLS Procleix Ultrio Elite Assay Positive Calibrators
PROCLEIX Ultrio Elite Assay Target Enhancer Reagent
PROCLEIX HEV Assay and Accessories
Xpert Xpress CoV-2 plus
CEPHEID (LODI)
DIASPECT Tm Analyzer with Accessories
EKF-DIAGNOSTIC GMBH
Xpert Xpress CoV-2 Flu RSV Plus
CEPHEID
ACTIM PROM
ACTIM OY
ACTIM PROM Control
ACTIM OY
ACTIM Partus
ACTIM OY
ACTIM Partus Controls
ACTIM LTD.
VACURATE Vacuum Blood Collection Lithium Heparin PET
PLASTI LAB SARL
GeneXpert Dx Instrument System GX-XVI
SANMINA SCI SYSTEMS SDN BHD
GeneXpert Dx Instrument System GX-IV
SANMINA SCI SYSTEMS SDN BHD

