Biokit, S.A.
Biokit, S.A. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2025, with 1 FDA device recall on record.
Top product codes for Biokit, S.A.
FDA recalls by Biokit, S.A.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biokit, S.A.
- K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- K233605 — ADVIA Centaur EBV-EBNA IgG
- K233606 — ADVIA Centaur EBV-VCA IgM
- K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- K214068 — Quantia IgE
- K181333 — ADVIA Centaur Herpes-1 IgG
- K181334 — ADVIA Centaur Herpes-2 IgG
- K152185 — ARCHITECT SHBG
- K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS
- K123947 — ARCHITECT IVANCOMYCIN
- K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
- K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
- K082141 — ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
- K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
- K072078 — QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
- K063232 — ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
- K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
- K060818 — ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
- K060027 — ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
- K050493 — QUANTIA IGE
- K050613 — QUANTIA BETA-2 MICROGLOBULIN
- K050596 — QUANTIA A1-AT
- K050487 — QUANTIA LA(A)
Data sourced from openFDA. This site is unofficial and independent of the FDA.