Elecsys HSV-2 IgG (08948887160)

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Hsv-2 Igg (08948887160).

Pre-market Notification Details

Device IDK220924
510k NumberK220924
Device Name:Elecsys HSV-2 IgG (08948887160)
ClassificationEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis,  IN  46250
ContactCynthia Aker
CorrespondentCynthia Aker
Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis,  IN  46250
Product CodeMYF  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-10-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336170694 K220924 000
07613336170687 K220924 000

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