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510(k) K061239

Device
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
Applicant
EUROIMMUN US LLC
510(k) number
K061239
Product code
MYF  
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-28
Date received
2006-05-03
Regulation
866.3305
Classification name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KATHRYN KOHL
Address
429 Rockaway Valley Rd. Unit 1200 Boonton Township NJ US 07005 07005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A.2025-02-12
K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics2022-10-12
K181514SeraQuest HSV Type 2 Specific IgGQuest International, Inc.2019-06-13
K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A.2018-08-23
K152353SeraQuest HSV Type 2 Specific IgGQuest International, Inc.2016-05-13
K103603ZEUS ELISA HSV GG-2 IGG TEST SYSTEMZeus Scientific, Inc.2011-05-20
K081687LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGGDiaSorin, Inc.2008-11-10
K033106CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KITTrinity Biotech USA2004-07-13
K993724HSV-2 ELISA IGG, MODEL EL0920GMrl Diagnostics2000-02-01

Legacy Summary#

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FDA Review#

Decision Summary