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Data / Medical devices / United States / Sekisui Diagnostics, LLC

Sekisui Diagnostics, LLC: FDA-registered device maker in San Diego, CA, United States, 18 510(k) clearances

Sekisui Diagnostics, LLC is registered with the FDA (registration 2030538) in San Diego, CA, United States. It lists 21 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 30, 2024. 2 recall events name it as the recalling firm. Registered through 2026. 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 Sekisui Diagnostics, LLC
FDA registration number
2030538
FEI number
1000520007
Address
6659 Top Gun St, San Diego, CA, United States, 92121
Owner or operator
Sekisui Diagnostics, LLC (10035388)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
February 25, 2011
Registered through
2026
Brand names listed
COVID-19 Antigen Home Test, OSOM COVID-19 Antigen Control Kit, OSOM COVID-19 Antigen Home Test, OSOM COVID-19 Antigen Rapid Test, OSOM Card Pregnancy Test, OSOM FLU Home Test, OSOM Flu SARS-CoV-2 Combo Control Kit, OSOM Flu SARS-CoV-2 Combo Home Test and more

Devices it lists

DeviceProduct codeClassRoleSource
Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Contract manufacturer, Manufacturer, Manufacturer for exportaccessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33GOD1Manufacturer for exportaccessdata.fda.gov
Antigens, Cf (Including Cf Control), Influenza Virus A, B, CGNX1Manufacturer for exportaccessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.GTZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Antisera, Fluorescent, Human MetapneumovirusOMG2Manufacturer for exportaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Repackager or relabeleraccessdata.fda.gov
Control, Fecal Occult BloodOSL2Complaint file establishmentaccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNComplaint file establishment, Manufactureraccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RotavirusLIQ1Manufacturer for exportaccessdata.fda.gov
Giardia Spp.MHI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Helicobacter PyloriLYR1Complaint file establishmentaccessdata.fda.gov
Kit, Quality Control For Culture MediaJTR1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Kit, Screening, TrichomonasJWZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Reagent, Occult BloodKHE2Complaint file establishmentaccessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsQVF2Repackager or relabeleraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufactureraccessdata.fda.gov
System, Test, Infectious MononucleosisKTN2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Test, Vaginal, Bacterial SialidaseMXB1Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.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
July 30, 2024K240280Nano-Check™ RSV TestGQGSubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
January 23, 2024K231187Nano-Check™ COVID-19 Antigen TestQVFSubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
April 3, 2020K192719Osom Ultra Plus Flu A&B Test KitPSZSubstantially EquivalentSEKISUI Diagnostics, LLCaccessdata.fda.gov
December 17, 2018K182001Acucy Influenza A&B Test with the Acucy SystemPSZSubstantially EquivalentSEKISUI Diagnostics, LLCaccessdata.fda.gov
June 22, 2018K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestKTNSubstantially EquivalentSEKISUI Diagnostics, LLCaccessdata.fda.gov
November 10, 2010K083746BIOSIGN FLU A+BPSZSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
July 1, 2010K100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TESTKHESubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
September 25, 2009K092633OSOM INFLUENZA A&B TEST , MODEL PN190PSZSubstantially EquivalentGenzyme Corporationaccessdata.fda.gov
April 12, 2005K043385OSOM HCG COMBO TESTJHISubstantially EquivalentGenzyme Diagnosticsaccessdata.fda.gov
April 6, 2005K050755MODIFICATION TO BVBLUEMXBSubstantially EquivalentGryphus Diagnostics, LLCaccessdata.fda.gov
April 2, 2004K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZSubstantially EquivalentGenzyme Corp.accessdata.fda.gov
January 18, 2000K992658OSOM ULTRA STREP A TEST, MODEL 147GTYSubstantially EquivalentWyntek Diagnostics, Inc.accessdata.fda.gov
January 11, 1999K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHISubstantially EquivalentGenzyme Diagnosticsaccessdata.fda.gov
September 22, 1998K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYRSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
December 24, 1997K974159OSOM HCG-URINE TEST MODEL 101JHISubstantially EquivalentWyntek Diagnostics, Inc.accessdata.fda.gov
October 11, 1996K961423OSOM STREP A TESTGTZSubstantially EquivalentWyntek Diagnostics, Inc.accessdata.fda.gov
December 6, 1995K955141OSOM HCG COMBO TESTJJXSubstantially EquivalentWyntek Diagnostics, Inc.accessdata.fda.gov
October 25, 1994K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEJHISubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
September 16, 201366294Class IITerminatedProduct Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technologSekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.accessdata.fda.gov
February 23, 200428473Not yet classifiedTerminatedGiardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/CrypotsporidiuFalse Positive results.accessdata.fda.gov

Compare with other makers

Updated July 30, 2024. 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.