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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Acetaminophen Calibrator	03R7401	FDA UDI	Class II	Active
CREATININE-S Assay	221-50	FDA UDI	Class II	Active
DC-TROL Level 1	SM-052	FDA UDI	Class I	Unknown
N-geneous LDL-ST Cholesterol Reagent (R2)	80-5714-00	FDA UDI	Class I	Active
ALT-SL Assay	318-30	FDA UDI	Class I	Active
Ammonia L3K	293-10	FDA UDI	Class I	Active
Uibc-Sl	153-10	FDA UDI	Class I	Active
HDL Ultra Cholesterol	6121	FDA UDI	Class I	Active
Acetaminophen L3k	506-10	FDA UDI	Class II	Unknown
Magnesium Assay	SK175-40	FDA UDI	Class I	Unknown
OSOM ULTRA PLUS FLU A&B Test	1032	FDA UDI	Class II	Active
Triglyceride	SK236-10	FDA UDI	Class I	Unknown
CREATININE-S Assay	221-30	FDA UDI	Class II	Active
LDL Cholesterol	SK5665-20	FDA UDI	Class I	Unknown
URIC ACID-SL Assay	237-60	FDA UDI	Class I	Active
LDL Direct LS Cholesterol Reagent Kit	7120	FDA UDI	Class I	Active
Acucy System	1039	FDA UDI	Class II	Unknown
IRON (Total)	102-15	FDA UDI	Class I	Unknown
CALCIUM Assay	140-24	FDA UDI	Class II	Unknown
N-geneous LDL-ST Cholesterol Calibrator	80-5666-02	FDA UDI	Class II	Active
ALBUMIN Assay	200-05	FDA UDI	Class II	Active
OSOM Influenza Control Kit	191	FDA UDI	Class I	Unknown
OSOM H Pylori 25 Test Kit	175	FDA UDI	Class I	Active
Salicylate Assay	SK511-50	FDA UDI	Class II	Unknown
OSOM H. Pylori Control Kit	176	FDA UDI	Class I	Active
Ast-Sl	319-30	FDA UDI	Class II	Active
CRP Ultra WR Reagent Kit	082	FDA UDI	Class II	Active
Ast	SK319-20	FDA UDI	Class II	Unknown
OSOM Ultra Flu Aspirate 25T Kit	1007	FDA UDI	Class II	Active
Albumin	SK200-10	FDA UDI	Class II	Unknown
N-geneous LDL Cholesterol Reagent (R1)	80-4598-00	FDA UDI	Class I	Active
Ethanol Assay	SK273-40	FDA UDI	Class II	Unknown
N-geneous LDL Cholesterol Reagent (R1)	80-4604-00	FDA UDI	Class I	Unknown
OSOM COVID-19 Antigen Rapid Test	1066-40	FDA UDI	N	Active
Hcg Serum Control Kit	138	FDA UDI	Class I	Active
Acetaminophen Assay	SK507-50	FDA UDI	Class II	Unknown
Creatine Kinase-Sl	326-10	FDA UDI	Class II	Active
Lactate Dehydrogenase Assay	SK327-20	FDA UDI	Class II	Unknown
IRON-SL Assay	157-30	FDA UDI	Class I	Active
Creatinine (enzymatic)	SK265-20	FDA UDI	Class II	Unknown
CARBON DIOXIDE L3K-C Assay	288-36	FDA UDI	Class II	Active
CARBON DIOXIDE L3K Assay	299-17	FDA UDI	Class II	Active
TOTAL PROTEIN (MICRO) Assay	450-50	FDA UDI	Class II	Unknown
OSOM hCG Urine 50 Test Kit	101	FDA UDI	Class II	Active
MICROALBUMIN Urine Level 1 and 2	SM-252	FDA UDI	Class I	Unknown
OSOM Combo hCG 25 Test kit	124	FDA UDI	Class II	Active
OSOM hCG Card 25 Test Kit	102W	FDA UDI	Class II	Active
ETHANOL L3K Assasy	273-30	FDA UDI	Class II	Active
Acetaminophen L3k	506-30	FDA UDI	Class II	Active
Urea	SK283-10	FDA UDI	Class II	Unknown

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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.