Biokit, S.A.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
23
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1021-2023Class IIbiokitHSV-2 Rapid Test, REF: 300028001September 28, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsFebruary 12, 2025
K233605ADVIA Centaur EBV-EBNA IgGAugust 7, 2024
K233606ADVIA Centaur EBV-VCA IgMAugust 7, 2024
K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsSeptember 20, 2023
K214068Quantia IgEFebruary 21, 2023
K181334ADVIA Centaur Herpes-2 IgGAugust 23, 2018
K181333ADVIA Centaur Herpes-1 IgGAugust 23, 2018
K152185ARCHITECT SHBGFebruary 11, 2016
K132400LP(A) CALIBRATORS, AND LP(A) CONTROLSDecember 19, 2013
K123947ARCHITECT IVANCOMYCINAugust 29, 2013
K110619ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLSNovember 23, 2011
K082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01December 22, 2008
K082141ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10September 3, 2008
K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01March 19, 2008
K072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307December 19, 2007
K063232ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8June 19, 2007
K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)June 8, 2007
K060818ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELJanuary 23, 2007
K060027ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)January 26, 2006
K050493QUANTIA IGEAugust 16, 2005