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Sekisui Diagnostics, LLC

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/
LinkedIn: linkedin.com/company/sekisui-diagnostics-llc
Facebook: facebook.com/profile.php
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000520007
DUNS Number: —

Catalogue (176)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
HbA1c Blank Solution	SK350-BLK	FDA UDI	Class II	Unknown
OSOM Ultra Flu A&B Controls 5 Test	1005	FDA UDI	Class I	Active
Wide Range CRP Multi-Calibrators	SE-250	FDA UDI	Class II	Unknown
OSOM Flu Dipstick 25 Test Kit	190	FDA UDI	Class I	Unknown
Alinity c Acetaminophen	07P5420	FDA UDI	Class II	Active
IMMUNOCARD STAT C/G Control Set	750820	FDA UDI	Class I	Active
OSOM hCG Urine Ctrl Set	134	FDA UDI	Class II	Active
CRP Ultra WR Calibrator	082B	FDA UDI	Class II	Active
Alkaline Phosphatase	SK328-40	FDA UDI	Class II	Unknown
N-geneous LDL Cholesterol Reagent (R2)	80-4601-00	FDA UDI	Class I	Active
Uric Acid Assay	SK237-40	FDA UDI	Class I	Unknown
Alt	SK318-20	FDA UDI	Class I	Unknown
ALBUMIN Assay	200-45	FDA UDI	Class II	Active
GGT Assay	334-10	FDA UDI	Class I	Active
Alinity c Acetaminophen Calibrator	07P5401	FDA UDI	Class II	Active
OSOM hCG Card 5 Test kit	102W-5	FDA UDI	Class II	Active
OSOM Flu SARS-CoV-2 Combo Home	1074	FDA UDI	N	Active
Total Bilirubin-Sl-X	284-10	FDA UDI	Class II	Unknown
Total Bilirubin-Sl-X	284-30	FDA UDI	Class II	Active
Glucose	SK235-10	FDA UDI	Class II	Unknown
Acucy Influenza A&B Test with the Acucy System	K182001	FDA 510(k)	Class II	Active
Osom Influenza A&B Test Model 190	K123182	FDA 510(k)	Class I	Active
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test	K181436	FDA 510(k)	Class II	Active
Osom Ultra Plus Flu A&B Test Kit	K192719	FDA 510(k)	Class II	Active
Osom Ifob 25 Test And Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit	K121397	FDA 510(k)	Class II	Active
Acucy® Influenza A&B Test with the Acucy® 2 System	K241188	FDA 510(k)	Class II	Active

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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.