Biokit, S.A.
LLISSA D AMUNT Barcelona, ES
BIOKIT S.A. appears in FDA device records in LLISSA D AMUNT Barcelona, ES. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Biokit, S.A. between 2005 and 2025. The busiest year on record is 2005, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 4 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 3 |
| 2011 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2018 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | MYF | Substantially Equivalent | |
| K233606 | ADVIA Centaur EBV-VCA IgM | LSE | Substantially Equivalent | |
| K233605 | ADVIA Centaur EBV-EBNA IgG | LLM | Substantially Equivalent | |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | MXJ | Substantially Equivalent | |
| K214068 | Quantia IgE | DGC | Substantially Equivalent | |
| K181334 | ADVIA Centaur Herpes-2 IgG | MYF | Substantially Equivalent | |
| K181333 | ADVIA Centaur Herpes-1 IgG | MXJ | Substantially Equivalent | |
| K152185 | ARCHITECT SHBG | CDZ | Substantially Equivalent | |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | JIT | Substantially Equivalent | |
| K123947 | ARCHITECT IVANCOMYCIN | LEH | Substantially Equivalent | |
| K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS | MRG | Substantially Equivalent | |
| K082953 | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 | KXT | Substantially Equivalent | |
| K082141 | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 | JIT | Substantially Equivalent | |
| K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 | LEH | Substantially Equivalent | |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | JZG | Substantially Equivalent | |
| K063232 | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 | CEW | Substantially Equivalent | |
| K070810 | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) | LGS | Substantially Equivalent | |
| K060818 | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 | CDZ | Substantially Equivalent | |
| K060027 | ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) | JJX | Substantially Equivalent | |
| K050613 | QUANTIA BETA-2 MICROGLOBULIN | JZG | Substantially Equivalent | |
| K050493 | QUANTIA IGE | DGC | Substantially Equivalent | |
| K050596 | QUANTIA A1-AT | DEM | Substantially Equivalent | |
| K050487 | QUANTIA LA(A) | DFC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610746 | 3002806557 | BIOKIT S.A. | AV. CAN MONTCAU 7, LLISSA D AMUNT Barcelona 08186 ES | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JJTEnzyme Controls (Assayed And Unassayed)
- KXTEnzyme Immunoassay, Digoxin
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- LSEEpstein-Barr Virus, Other
- DBTFactor Xiii A, S, Antigen, Antiserum, Control
- DBFFerritin, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- LGSFluorescence Polarization Immunoassay, Theophylline
- DGCIge, Antigen, Antiserum, Control
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GGNPlasma, Coagulation Control
- LCOPlatelet Factor 4 Radioimmunoassay
- SEIQualitative And Quantitative Hepatitis B Virus Antibody Assays
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CEWRadioimmunoassay, Parathyroid Hormone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- LEHRadioimmunoassay, Vancomycin
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- MIDSystem, Test, Anticardiolipin Immunological
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- MRGSystem, Test, Vitamin D
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
- LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- GGPTest, Qualitative And Quantitative Factor Deficiency
- LPSUrinary Homocystine (Nonquantitative) Test System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1021-2023 | biokitHSV-2 Rapid Test, REF: 300028001 | HSV-2 rapid test may report false positive results. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain