ADVIA Centaur Herpes-1 IgG

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Biokit, S.A.

The following data is part of a premarket notification filed by Biokit, S.a. with the FDA for Advia Centaur Herpes-1 Igg.

Pre-market Notification Details

Device IDK181333
510k NumberK181333
Device Name:ADVIA Centaur Herpes-1 IgG
ClassificationEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant Biokit, S.A. Can Male S/N Llica D’amunt,  ES 08186
ContactJoan Guixer
CorrespondentJoan Guixer
Biokit, S.A. Can Male S/N Llica D’amunt,  ES 08186
Product CodeMXJ  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-21
Decision Date2018-08-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414016740 K181333 000
00842768022784 K181333 000

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