Biokit, S.A.
Medical device manufacturer in Lliçà DAmunt, Barcelona, ES.
23510(k) clearances
0PMA approvals
1recalls
Device types
- DGC Ige, Antigen, Antiserum, Control 2
- JZG System, Test, Beta-2-Microglobulin… 2
- CDZ Radioimmunoassay, Testosterones And… 2
- LEH Radioimmunoassay, Vancomycin 2
- JIT Calibrator, Secondary 2
- MXJ Enzyme Linked Immunosorbent Assay, Herpes… 2
- MYF Enzyme Linked Immunosorbent Assay, Herpes… 2
- DFC Lipoprotein, Low-Density, Antigen… 1
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
- JJX Single (Specified) Analyte Controls… 1
- LGS Fluorescence Polarization Immunoassay… 1
- CEW Radioimmunoassay, Parathyroid Hormone 1
- KXT Enzyme Immunoassay, Digoxin 1
- MRG System, Test, Vitamin D 1
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
- LSE Epstein-Barr Virus, Other 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF · Traditional | 02/12/2025SE |
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | 08/07/2024SE |
| K233605 | ADVIA Centaur EBV-EBNA IgGLLM · Traditional | 08/07/2024SE |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | 09/20/2023SE |
| K214068 | Quantia IgEDGC · Special | 02/21/2023SE |
| K181334 | ADVIA Centaur Herpes-2 IgGMYF · Traditional | 08/23/2018SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | 08/23/2018SE |
| K152185 | Architect SHBGCDZ · Traditional | 02/11/2016SE |
| K132400 | Lp(A) Calibrators, and Lp(A) ControlsJIT · Abbreviated | 12/19/2013SE |
| K123947 | Architect IvancomycinLEH · Traditional | 08/29/2013SE |
| K110619 | Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsMRG · Traditional | 11/23/2011SE |
| K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01KXT · Traditional | 12/22/2008SE |
| K082141 | Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10JIT · Abbreviated | 09/03/2008SE |
| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…LEH · Traditional | 03/19/2008SE |
| K072078 | Quantia BETA-2 Microglobulin, Model: 302822307JZG · Traditional | 12/19/2007SE |
| K063232 | Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High)…CEW · Traditional | 06/19/2007SE |
| K070810 | Architect I Theophylline Reagents and Calibrators (A-F)LGS · Traditional | 06/08/2007SE |
| K060818 | Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…CDZ · Traditional | 01/23/2007SE |
| K060027 | Architect Dhea-S Calibrators (A-F) and Controls (Low, Medium and High)JJX · Traditional | 01/26/2006SE |
| K050613 | Quantia BETA-2 MicroglobulinJZG · Traditional | 08/16/2005SE |
| K050493 | Quantia IgeDGC · Traditional | 08/16/2005SE |
| K050596 | Quantia A1-ATDEM · Traditional | 05/13/2005SE |
| K050487 | Quantia La(A)DFC · Traditional | 04/26/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1021-2023 Class II | biokitHSV-2 Rapid Test, REF: 300028001HSV-2 rapid test may report false positive results. | 09/28/2022Open, Classified |