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Sign in to claim this brandSekisui Diagnostics, LLC
US
Last updated September 17, 2026
About
SEKISUI Diagnostics develops, manufactures, and distributes clinical chemistry reagents, point-of-care rapid diagnostic tests, enzymes, specialty biochemicals, and pre-analytic systems for healthcare professionals, laboratories, manufacturers, and distributors worldwide. With over 40 years in diagnostics and more than 1.8 billion tests performed annually, SEKISUI delivers dependable solutions to improve patient outcomes globally.
From the manufacturer's own website. Source
Information
- Country
- US
- Address
- 6659 Top Gun St, SAN DIEGO, CA, 92121
- Website
- sekisuidiagnostics.com/
- facebook.com/profile.php
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000520007
- DUNS Number
- —
Catalogue (176)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DC-TROL Level 2 | SM-056 | FDA UDI | Class I | Unknown |
| OSOM Vaginal Transport Swab Set | 185 | FDA UDI | Class I | Active |
| OSOM Ultra hCG 25T Kit | 1004 | FDA UDI | Class II | Active |
| DC-Lineate | SE-091 | FDA UDI | Class II | Active |
| Uibc-Sl | 153-30 | FDA UDI | Class I | Active |
| OSOM Flu SARS-CoV-2 Combo Test | 1080 | FDA UDI | N/A | Active |
| Total Bilirubin L3k | 295-30 | FDA UDI | Class II | Unknown |
| Uibc-Sl | 153-90 | FDA UDI | Class I | Active |
| Cholesterol | SK234-10 | FDA UDI | Class I | Unknown |
| IRON (Total) | 102-25 | FDA UDI | Class I | Unknown |
| OSOM RSV Test Home | 1091 | FDA UDI | Class I | Active |
| CARBON DIOXIDE L3K Assay | 299-30 | FDA UDI | Class II | Active |
| Liquid Select Amylase Reagent | 80-5451-00 | FDA UDI | Class II | Active |
| Total Bilirubin | SK284-20 | FDA UDI | Class II | Unknown |
| CARBON DIOXIDE L3K Assay | 299-80 | FDA UDI | Class II | Unknown |
| Phosphorus | SK117-20 | FDA UDI | Class I | Unknown |
| MAGNESIUM Reagent | 175-12 | FDA UDI | Class I | Active |
| GGT Assay | SK334-20 | FDA UDI | Class I | Unknown |
| URIC ACID-SL Assay | 237-99 | FDA UDI | Class I | Active |
| Carbon Dioxide | SK299-10 | FDA UDI | Class II | Unknown |
| MONO, MERIDIAN IMMUNO 25 Test Kit | 755725 | FDA UDI | Class II | Active |
| OSOM Strep A 50 Test Kit | 141 | FDA UDI | Class I | Active |
| SALICYLATE-SL Assay | 511-40 | FDA UDI | Class II | Active |
| HCG COMBO, MERIDIAN 25 test Kit | 755425 | FDA UDI | Class II | Active |
| OSOM Mono 25 Test Kit | 145 | FDA UDI | Class II | Active |
| OSOM Trich.10T Cntrl Kit | 182 | FDA UDI | Class I | Active |
| CARBON DIOXIDE L3K Assay | 299-55 | FDA UDI | Class II | Active |
| Urea-L3k | 283-99 | FDA UDI | Class II | Active |
| Alkaline Phosphatase | SK328-20 | FDA UDI | Class II | Unknown |
| Acucy Calibration Device | 1031 | FDA UDI | Class II | Unknown |
| Ultra N-geneous HDL Cholesterol Reagent | 80-6283-00 | FDA UDI | Class I | Active |
| Alkaline Phosphatase-Sl | 328-30 | FDA UDI | Class II | Active |
| OSOM Strep A 10 Test Kit | 141-10 | FDA UDI | Class I | Active |
| HDL Ultra Cholesterol | 6122 | FDA UDI | Class I | Active |
| Direct Bilirubin | SK247-20 | FDA UDI | Class II | Unknown |
| DC-CAL Calibrator | SE-035 | FDA UDI | Class II | Active |
| CRP ULTRA (Wide Range) | SK250-30 | FDA UDI | Class II | Unknown |
| Acucy Flu Test Kit | 1010 | FDA UDI | Class II | Active |
| STREP A, MERIDIAN IMMUNO 50 Test Kit | 755250 | FDA UDI | Class I | Active |
| N-geneous LDL Cholesterol Calibrator | 80-4610-02 | FDA UDI | Class II | Active |
| N-geneous LDL-ST Cholesterol Reagent (R1) | 80-5727-02 | FDA UDI | Class I | Active |
| OSOM iFOB Control Kit | 1000 | FDA UDI | Class II | Active |
| CARBON DIOXIDE L3K-C Assay | 288-80 | FDA UDI | Class II | Unknown |
| GLUCOSE-SL Assay | 235-60 | FDA UDI | Class II | Active |
| OSOM Trich V. 5 Test Kit | 181-5 | FDA UDI | Class I | Active |
| OSOM COVID-19 Antigen Home Test | 1067-40 | FDA UDI | N | Active |
| Acucy Influenza A&B Control Kit | 1011 | FDA UDI | Class II | Active |
| Urea-L3k | 283-30 | FDA UDI | Class II | Active |
| Glucose-Sl | 235-99 | FDA UDI | Class II | Active |
| N-geneous LDL Cholesterol Reagent (R2) | 80-4607-00 | FDA UDI | Class I | Unknown |
Related Companies
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Importers
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 16, 2013 | Z-0015-2014 | — | terminated | 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. |
| Oct 24, 2012 | Z-0463-2013 | — | terminated | 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. |
| Aug 28, 2012 | Z-2431-2012 | — | terminated | 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. |
| May 29, 2012 | Z-1902-2012 | — | terminated | Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. |