Sekisui Diagnostics, LLC
San Diego, CA, US
Sekisui Diagnostics, LLC appears in FDA device records in San Diego, CA. FDA records list 21 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Sekisui Diagnostics, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- American Diagnostica, Inc.510(k), recall
- Genzyme Diagnostics510(k), recall
510(k) clearance history
FDA records hold 21 510(k) clearances for Sekisui Diagnostics, LLC between 1994 and 2025. The busiest year on record is 2002, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 4 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2012 | 2 |
| 2018 | 2 |
| 2020 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | PSZ | Substantially Equivalent | |
| K192719 | Osom Ultra Plus Flu A&B Test Kit | PSZ | Substantially Equivalent | |
| K182001 | Acucy Influenza A&B Test with the Acucy System | PSZ | Substantially Equivalent | |
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | KTN | Substantially Equivalent | |
| K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | KHE | Substantially Equivalent | |
| K123182 | OSOM INFLUENZA A&B TEST MODEL 190 | GNX | Substantially Equivalent | |
| K080069 | DIMERTEST | DAP | Substantially Equivalent | |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | GGP | Substantially Equivalent | |
| K052124 | ACTICLOT, MODEL 824 | GJS | Substantially Equivalent | |
| K043385 | OSOM HCG COMBO TEST | JHI | Substantially Equivalent | |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | KFF | Substantially Equivalent | |
| K013492 | IMUBIND TPA ELISA, MODEL 860 | GGP | Substantially Equivalent | |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | KFF | Substantially Equivalent | |
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | GGP | Substantially Equivalent | |
| K012386 | ACTICLOT PROTEIN S, MODEL 843L | GGP | Substantially Equivalent | |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | MHI | Substantially Equivalent | |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | KTN | Substantially Equivalent | |
| K964156 | CONTRAST STRIP HCG | JHI | Substantially Equivalent | |
| K964155 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST | JHI | Substantially Equivalent | |
| K940490 | DV TEST AND DVV CONFIRM | GIR | Substantially Equivalent | |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | GIZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2030538 | 1000520007 | Sekisui Diagnostics, LLC | 6659 Top Gun St, SAN DIEGO, CA 92121 US | 2026 | and 11 more, listed in full below |
| 3017772438 | 3017772438 | Sekisui Diagnostics, LLC | 6740 Cobra Way, San Diego, CA 92121 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GTYAntigens, All Groups, Streptococcus Spp.
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GTZAntisera, All Groups, Streptococcus Spp.
- OMGAntisera, Fluorescent, Human Metapneumovirus
- KXGApplicator, Absorbent Tipped, Sterile
- KFFAssay, Heparin
- OSLControl, Fecal Occult Blood
- QKPCoronavirus Antigen Detection Test System.
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- MHIGiardia Spp.
- LYRHelicobacter Pylori
- JTRKit, Quality Control For Culture Media
- JWZKit, Screening, Trichomonas
- GIZPlasma, Control, Normal
- KHEReagent, Occult Blood
- GIRReagent, Russel Viper Venom
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KTNSystem, Test, Infectious Mononucleosis
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJSTest, Time, Prothrombin
- MXBTest, Vaginal, Bacterial Sialidase
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0015-2014 | Product 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 technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD. | Sekisuki 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. | Class II | Terminated | |
| Z-0463-2013 | Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use. | Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions. | Class II | Terminated | |
| Z-2431-2012 | Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use. | SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions. | Class II | Terminated | |
| Z-1902-2012 | MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. | Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. | Class II | Terminated | |
| Z-1426-2010 | REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma. | Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators | Terminated | ||
| Z-0779-2007 | American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic | Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas | Terminated | ||
| Z-0770-04 | Giardia/ 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/Crypotsporidium Rapid Assay | False Positive results. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Sekisui Diagnostics, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain