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510(k) K181334

Device
ADVIA Centaur Herpes-2 IgG
Applicant
Biokit, S.A.
510(k) number
K181334
Product code
MYF  
Decision
Substantially Equivalent (SESE)
Decision date
2018-08-23
Date received
2018-05-21
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joan Guixe
Address
Can Male S/N Lliça D'Amunt ES 08186 08186

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITEuroimmun Us, LLC2007-06-28
K033106CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KITTrinity Biotech USA2004-07-13
K993724HSV-2 ELISA IGG, MODEL EL0920GMrl Diagnostics2000-02-01

Legacy Summary#

summary

FDA Review#

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