Is this your brand? Sign in to claim ownership.

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 3 of 4

Device	Model / Reference	Registries	Class	Status
HDL Ultra Calibrator Kit	6272-3	FDA UDI	Class II	Active
Carbon Dioxide L3K	299-50	FDA UDI	Class II	Active
LACTATE DEHRYDROGENASE-SL Assay	327-30	FDA UDI	Class II	Active
Acetaminophen L3K Assay	507-30	FDA UDI	Class II	Active
Creatine Kinase Assay	SK326-20	FDA UDI	Class II	Unknown
TOTAL BILIRUBIN-SL Assay	243-10	FDA UDI	Class II	Unknown
Wide Range CRP Assay	250-20	FDA UDI	Class II	Unknown
ImmunoStat G/C 30 Test Kit	750830	FDA UDI	Class II	Active
OSOM Ultra Flu A&B 25T Kit	1006	FDA UDI	Class II	Active
Amylase Assay	SK5383-40	FDA UDI	Class II	Unknown
PHOSPHORUS-SL Assay	117-30	FDA UDI	Class I	Active
Cholesterol-Sl	234-99	FDA UDI	Class I	Active
LIPASE Color	905-B	FDA UDI	Class I	Active
OSOM iFOBT Stool Collection Tube	1001	FDA UDI	Class II	Active
OSOM Trich V. 25 Test Kit	181	FDA UDI	Class I	Active
Uibc-Sl	153-50	FDA UDI	Class I	Active
MICROALBUMIN Calibrators	SE-252	FDA UDI	Class II	Active
OSOM Ultra Strep A 25 Test Kit	147	FDA UDI	Class I	Active
Microalbumin	SK252-20	FDA UDI	Class II	Unknown
HbA1c Calibrators	SK350-CAL	FDA UDI	Class II	Unknown
Liquid Select Amylase Reagent	80-5383-00	FDA UDI	Class II	Active
OSOM Ultra Strep A 5 Test Kit	148	FDA UDI	Class I	Active
Triglyceride-Sl	236-60	FDA UDI	Class I	Active
Calcium	SK140-10	FDA UDI	Class II	Unknown
Iron	SK157-20	FDA UDI	Class I	Unknown
Acetaminophen	03R7420	FDA UDI	N/A	Active
HbA1c Assay	SK350-60	FDA UDI	Class II	Unknown
Total Protein	200-55	FDA UDI	Class II	Active
Total Protein	SK201-10	FDA UDI	Class II	Unknown
OSOM COVID-19 Antigen Control Kit	1068	FDA UDI	N	Active
CALCIUM Assay	140-20	FDA UDI	Class II	Active
DIRECT BILIRUBIN-SL Assay	247-30	FDA UDI	Class II	Active
ENZYMATIC CREATININE Assay	265-30	FDA UDI	Class II	Active
Cholesterol-Sl	234-60	FDA UDI	Class I	Active
OSOM iFOB 25T Kit	1002	FDA UDI	Class II	Active
HDL Ultra Cholesterol Reagent	SK6122-20	FDA UDI	Class I	Unknown
OSOM Flu SARS-CoV-2 Combo Control Kit	1079	FDA UDI	N	Active
Dc-Uibc-Cal	SE-090	FDA UDI	Class II	Unknown
MICROALBUMIN Assay	252-20	FDA UDI	Class II	Active
Dc-Trol Levels 1 & 2	SM-057	FDA UDI	Class I	Active
OSOM ULTRA PLUS FLU A&B Control Kit	1034	FDA UDI	Class II	Active
N-geneous LDL-ST Cholesterol Reagent (R1)	80-5665-01	FDA UDI	Class I	Active
HbA1c Controls	SK350-QC	FDA UDI	Class I	Unknown
OSOM Ultra Strep A 50 Test Kit	149	FDA UDI	Class I	Active
Ultra N-geneous HDL Cholesterol Calibrator	80-6449-00	FDA UDI	Class II	Active
Dc-Uibc-Cal	SE-090	FDA UDI	Class II	Active
Triglyceride-Sl	236-99	FDA UDI	Class I	Active
N-geneous LDL-ST Cholesterol Reagent (R2)	80-5729-02	FDA UDI	Class I	Active
OSOM hCG Urine 10 Test Kit	101-10	FDA UDI	Class II	Active
Ultra N-geneous HDL Cholesterol Reagent	80-6277-00	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.