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Data / Medical devices / Spain / Biokit S.A.

Biokit S.A.: FDA-registered device maker in LLISSA D AMUNT Barcelona, Spain, 38 510(k) clearances and 1 PMA approval

Biokit S.A. is registered with the FDA (registration 9610746) in LLISSA D AMUNT Barcelona, Spain. It lists 40 device types. The FDA files 38 510(k) clearances and 1 PMA approval under its listings, the newest dated February 12, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Biokit S.A.
FDA registration number
9610746
FEI number
3002806557
Address
Av. Can Montcau 7, LLISSA D AMUNT Barcelona, Spain, 08186
Owner or operator
BIOKIT S.A. (8030752)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
April 10, 1980
Registered through
2027
Brand names listed
ADVIA Centaur EBV-EBNA IgG, ADVIA Centaur EBV-EBNA IgG Quality Control, ADVIA Centaur EBV-VCA IgM, ADVIA Centaur EBV-VCA IgM Quality Control, ADVIA Centaur Herpes-1 IgG (HSV1), ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control, ADVIA Centaur Herpes-2 IgG (HSV2), ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control and more

Devices it lists

DeviceProduct codeClassRoleSource
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Exporter to the US, Repackager or relabeler, Specification developeraccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Exporter to the US, Repackager or relabeler, Specification developeraccessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O ReagentGTQ1Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator, PrimaryJIS2Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator, SecondaryJIT2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)JJS1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Controls (Assayed And Unassayed)JJT1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificLGC2Manufactureraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1MXJ2Manufactureraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2MYF2Manufactureraccessdata.fda.gov
Epstein-Barr Virus, OtherLSE1Contract manufactureraccessdata.fda.gov
Factor Xiii A, S, Antigen, Antiserum, ControlDBT1Exporter to the US, Repackager or relabeler, Specification developeraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Manufactureraccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Manufacturer, Specification developeraccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Manufactureraccessdata.fda.gov
Ige, Antigen, Antiserum, ControlDGC2Exporter to the US, Repackager or relabeler, Specification developeraccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Repackager or relabeler, Specification developeraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Plasma, Coagulation ControlGGN2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Platelet Factor 4 RadioimmunoassayLCO2Contract manufacturer, Manufactureraccessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody AssaysSEI2Manufactureraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Manufactureraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Manufactureraccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Manufactureraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Manufactureraccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Contract manufacturer, Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Multipurpose For In Vitro Coagulation StudiesJPA2Manufacturer, Specification developeraccessdata.fda.gov
System, Test, Anticardiolipin ImmunologicalMID2Contract manufacturer, Manufactureraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Manufactureraccessdata.fda.gov
System, Test, Infectious MononucleosisKTN2Manufactureraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Manufactureraccessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)MSV2Contract manufacturer, Manufactureraccessdata.fda.gov
Test, Antigen, Nuclear, Epstein-Barr VirusLLM1Contract manufactureraccessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2Manufactureraccessdata.fda.gov
Test, Qualitative And Quantitative Factor DeficiencyGGP2Contract manufacturer, Manufactureraccessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test SystemLPS2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 12, 2025K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYFSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
January 28, 2025K243374HemosIL CL HIT-IgG(PF4-H)LCOSubstantially EquivalentInstrumentation Laboratory (IL) Co.accessdata.fda.gov
September 29, 2023K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPASubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
September 20, 2023K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
February 21, 2023K214068Quantia IgEDGCSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
December 9, 2022K223402HemosIL von Willebrand Factor AntigenGGPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
August 23, 2018K181334ADVIA Centaur Herpes-2 IgGMYFSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
August 23, 2018K181333ADVIA Centaur Herpes-1 IgGMXJSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
November 22, 2017K172903HemosIL D-Dimer HS 500DAPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
March 3, 2017K170314ACL AcuStarJPASubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
October 27, 2016K160885HemosIL D-Dimer HSDAPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
July 8, 2016K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsLCOSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
August 15, 2014K133582HEMOSIL D-DIMER HS 500 CONTROLGGNSubstantially EquivalentInstrumentation Laboratoryaccessdata.fda.gov
March 13, 2014K133005HEMOSIL VON WILLEBRAND ACTIVITY ASSAYGGPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
December 19, 2013K132400LP(A) CALIBRATORS, AND LP(A) CONTROLSJITSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
August 29, 2013K123947ARCHITECT IVANCOMYCINLEHSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
February 5, 2010K090264HEMOSIL D-DIMER HS 500, CONTROLSDAPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
March 13, 2009K083518ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLSJPASubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
December 22, 2008K082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01KXTSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
September 3, 2008K082141ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10JITSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
July 31, 2008K073042HEMOSIL D-DIMERDAPSubstantially EquivalentInstrumentation Laboratoryaccessdata.fda.gov
September 17, 2007K070927HEMOSIL D-DIMER HSDAPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
June 19, 2007K063232ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01CEWSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
June 8, 2007K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)LGSSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
January 23, 2007K060818ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01CDZSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
September 22, 2006K061598HEMOSIL HOMOCYSTEINE AND CONTROLSLPSSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
January 26, 2006K060027ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)JJXSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
August 16, 2005K050613QUANTIA BETA-2 MICROGLOBULINJZGSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
August 16, 2005K050493QUANTIA IGEDGCSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
May 13, 2005K050596QUANTIA A1-ATDEMSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
April 26, 2005K050487QUANTIA LA(A)DFCSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
May 10, 2004K040879QUANTEX FERRITINDBFSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
April 13, 2001K010379IL TEST FREE PROTEIN SGGPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
February 2, 1999K984437QUANTEX ASO-CRP-RP CONTROL IIJJTSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
May 27, 1997K971777QUANTEX ASO-CRP-RF CONTROLJJTSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
April 5, 1991K910539RHEUMAJET RFDHRSubstantially EquivalentBiokit USA, Inc.accessdata.fda.gov
October 24, 1989K894486QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)GTQSubstantially EquivalentBiokit USA, Inc.accessdata.fda.gov
December 14, 1987K874678I.M.N. LATEXKTNSubstantially EquivalentBiokit USA, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
July 14, 2021P200017ADVIA Centaur Anti-HBe2 (aHBe2) assaySEI4October 17, 2025accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 28, 202291384Class IIOngoingbiokitHSV-2 Rapid Test, REF: 300028001HSV-2 rapid test may report false positive results.accessdata.fda.gov

Compare with other makers

Updated October 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.