# Biokit, S.A.

- Location (FDA's records): Barcelona, ES
- FDA decisions: 23 (2005–2025): 23 510(k) clearances
- Product codes: JIT (2), CDZ (2), JZG (2), LEH (2), DGC (2), MXJ (2), MYF (2), MRG (1), LGS (1), DEM (1), KXT (1), DFC (1)
- Predicates its devices cite: 23 (4 its own); citations of its devices by later devices: 9 (4 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mrl Diagnostics: 4 (https://510kreport.com/company/mrl-diagnostics)
- DiaSorin, Inc.: 3 (https://510kreport.com/company/diasorin)
- Bayer Diagnostics Corp.: 2 (https://510kreport.com/company/bayer-diagnostics)
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Behring Diagnostics, Inc.: 1 (https://510kreport.com/company/behring-diagnostics)
- Seradyn, Inc.: 1 (https://510kreport.com/company/seradyn)

## Firms that cite its devices most
- Tosoh Bioscience, Inc.: 1 (https://510kreport.com/company/tosoh-bioscience)
- Nanoentek USA, Inc.: 1 (https://510kreport.com/company/nanoentek-usa)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Its most-cited devices
- K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls (2011), cited by 3
- K060818: Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01 (2007), cited by 2
- K072036: Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01 (2008), cited by 1
- K050487: Quantia LA (a) (2005), cited by 1
- K050493: Quantia Ige (2005), cited by 1
- K063232: Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01 (2007), cited by 1

## Recent decisions
- K243575: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (Feb 12, 2025)
- K233606: ADVIA Centaur EBV-VCA IgM (Aug 7, 2024)
- K233605: ADVIA Centaur EBV-EBNA IgG (Aug 7, 2024)
- K213987: ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (Sep 20, 2023)
- K214068: Quantia IgE (Feb 21, 2023)
- K181333: ADVIA Centaur Herpes-1 IgG (Aug 23, 2018)
- K181334: ADVIA Centaur Herpes-2 IgG (Aug 23, 2018)
- K152185: Architect SHBG (Feb 11, 2016)

Source page: https://510kreport.com/company/biokit