FDA.reportPublic FDA data

510(k) K151046

Device
Illumigene HSV 1&2 DNA Amplification Assay, Illumigene HSV 1&2 External Control Kit, Illumipro-10
Applicant
MERIDIAN BIOSCIENCE, INC.
510(k) number
K151046
Product code
PGI  
Decision
Substantially Equivalent (SESE)
Decision date
2015-07-17
Date received
2015-04-20
Regulation
866.3309
Classification name
Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEFANIE JOHNS
Address
3471 River Hills Dr. Cincinnati OH US 45244 45244

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PGI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.2024-05-03
K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation2023-12-20
K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC2019-11-26
K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup2018-10-29
K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLC2018-03-14
K162451Solana HSV 1+2/VZV AssayQuidel Corporation2016-11-28
K151906ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)Luminex Corporation2015-10-06
DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAYDiagnostic Hybrids, Inc.2014-05-13

Legacy Summary#

summary

FDA Review#

Decision Summary