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Biokit, S.A.

23 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575)Biokit, S.A.2025-02-12
ADVIA Centaur EBV-EBNA IgG (K233605)Biokit, S.A.2024-08-07
ADVIA Centaur EBV-VCA IgM (K233606)Biokit, S.A.2024-08-07
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987)Biokit, S.A.2023-09-20
Quantia IgE (K214068)Biokit, S.A.2023-02-21
ADVIA Centaur Herpes-1 IgG (K181333)Biokit, S.A.2018-08-23
ADVIA Centaur Herpes-2 IgG (K181334)Biokit, S.A.2018-08-23
ARCHITECT SHBG (K152185)Biokit, S.A.2016-02-11
LP(A) CALIBRATORS, AND LP(A) CONTROLS (K132400)Biokit, S.A.2013-12-19
ARCHITECT IVANCOMYCIN (K123947)Biokit, S.A.2013-08-29
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS (K110619)Biokit, S.A.2011-11-23
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 (K082953)Biokit, S.A.2008-12-22
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 (K082141)Biokit, S.A.2008-09-03
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 (K072036)Biokit, S.A.2008-03-19
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078)Biokit, S.A.2007-12-19
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 (K063232)Biokit, S.A.2007-06-19
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (K070810)Biokit, S.A.2007-06-08
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 (K060818)Biokit, S.A.2007-01-23
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) (K060027)Biokit, S.A.2006-01-26
QUANTIA IGE (K050493)Biokit, S.A.2005-08-16
QUANTIA BETA-2 MICROGLOBULIN (K050613)Biokit, S.A.2005-08-16
QUANTIA A1-AT (K050596)Biokit, S.A.2005-05-13
QUANTIA LA(A) (K050487)Biokit, S.A.2005-04-26

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