Data / Medical devices / Canada / Sekisui Diagnostics P.E.I. Inc.

Sekisui Diagnostics P.E.I. Inc.: FDA-registered device maker in CHARLOTTETOWN Prince Edward Island, Canada, 52 510(k) clearances

Name: Sekisui Diagnostics P.E.I. Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sekisui Diagnostics P.E.I. Inc. is registered with the FDA (registration 8020316) in CHARLOTTETOWN Prince Edward Island, Canada. It lists 47 device types. The FDA files 52 510(k) clearances under its listings, the newest dated February 18, 2022. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Sekisui Diagnostics P.E.I. Inc.

FDA registration number: 8020316
FEI number: 3002806809
Address: 70 Watts Avenue, CHARLOTTETOWN Prince Edward Island, Canada, C1E 2B9
Owner or operator: Sekisui Diagnostics, LLC (10035388)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: February 24, 2011
Registered through: 2026
Brand names listed: ALT-SL, Acetaminophen, Acetaminophen Assay, Acetaminophen Cal, Acetaminophen L3K, Acetaminophen L3K Assay, Acetaminophen SL, Alanine Amino Transferase L3K and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Uric, Uricase (Colorimetric)	KNK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Albumin, Antigen, Antiserum, Control	DCF	2	Manufacturer	accessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Contract manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Contract manufacturer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Contract manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Repackager or relabeler	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colorimetry, Acetaminophen	LDP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colorimetry, Salicylate	DKJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Contract manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Method, Ammonia	JIF	1	Manufacturer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Contract manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 18, 2022	K202644	Acetaminophen	LDP	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.	accessdata.fda.gov
February 8, 2019	K180835	SEKURE Acetaminophen L3K Assay	LDP	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.	accessdata.fda.gov
December 8, 2016	K163078	DC-UIBC-CAL	JIT	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.	accessdata.fda.gov
December 2, 2011	K111915	MAGNESIUM ASSAY	JGJ	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.	accessdata.fda.gov
May 1, 2009	K081938	ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30	LDP	Substantially Equivalent	Genzyme Diagnostics P.E.I., Inc.	accessdata.fda.gov
June 22, 2007	K070383	ENZYMATIC CREATININE ASSAY (265 SERIES)	JFY	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
January 19, 2007	K063208	MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7	JGJ	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
July 5, 2005	K051191	DCL MICROALBUMIN ASSAY, MODEL 252-20	DCF	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
January 7, 2005	K042330	ACETAMINOPHEN-SL ASSAY	LDP	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
December 27, 2004	K042362	MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12	KHS	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
December 27, 2004	K042329	SALICYLATE-SL ASSAY	DKJ	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
October 4, 2004	K042243	MICROALBUMIN MULTI-CALIBRATOR SET	JIX	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
March 10, 2004	K033921	AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10	JIF	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
June 2, 2003	K030546	CRP (II) CALIBRATORS	JIS	Substantially Equivalent	Denka Seiken Co., Ltd.	accessdata.fda.gov
June 2, 2003	K030545	CRP-LATEX (II)X2 SEIKEN ASSAY KIT	DCK	Substantially Equivalent	Denka Seiken Co., Ltd.	accessdata.fda.gov
January 17, 2003	K023739	GLUCOSE-SL-C ASSAY, MODEL 257-30	CFR	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
December 11, 2002	K023330	BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30	CIG	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
July 25, 2002	K021316	ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR	LBS	Substantially Equivalent	Genzyme Corp.	accessdata.fda.gov
May 14, 2002	K020816	IRON-PC-SL ASSAY MODEL # 151-10, 151-26	JIY	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
August 10, 2001	K011843	GENZYME DIRECT-AMYLASE TEST REAGENT	JFJ	Substantially Equivalent	Genzyme Corp.	accessdata.fda.gov
November 27, 2000	K003093	ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30	CJE	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
September 26, 2000	K002354	CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80	KHS	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
September 15, 2000	K002694	UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30	CDQ	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
June 20, 2000	K001286	ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10	DIC	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
February 18, 2000	K000055	CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17	CGX	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
October 18, 1999	K992766	N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET	MRR	Substantially Equivalent	Genzyme Corp.	accessdata.fda.gov
June 3, 1998	K981609	BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30	CIG	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
March 11, 1998	K973999	CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30	CGS	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
February 12, 1998	K974874	BILIRUBIN-SL (TOTAL) ASSAY	CIG	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
January 30, 1998	K974858	PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30	CEO	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
December 5, 1997	K974003	ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30	CKA	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
November 13, 1997	K974001	ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30	CIT	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
November 4, 1997	K974000	Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30	JQB	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
November 4, 1997	K973933	SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30	JIY	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
June 18, 1997	K971573	N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET	LBR	Substantially Equivalent	Genzyme Corp.	accessdata.fda.gov
June 16, 1997	K971162	LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR	LBS	Substantially Equivalent	Genzyme Corp.	accessdata.fda.gov
August 20, 1996	K963116	UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY	JMO	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
August 16, 1996	K961281	TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60	CDT	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
July 23, 1996	K961586	URIC ACID-SL ASSAY CATALOGUE NO. 237-60	KNK	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
June 21, 1996	K961282	GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60	CFR	Substantially Equivalent	Diagnostic Chemicals , Ltd.	accessdata.fda.gov
August 2, 1994	K932556	AMMONIA ASSAY CAT. NO. 200-02	JIF	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
August 19, 1993	K932555	DC-LINEATE CAT. NO. SE-091	JIS	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
February 26, 1990	K897150	LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT	CHI	Substantially Equivalent	Toyo Jozo Co., Ltd.	accessdata.fda.gov
December 12, 1989	K896073	CHOLESTEROL, UNIVERSAL ET	CHH	Substantially Equivalent	Enzyme Technology, Inc.	accessdata.fda.gov
December 12, 1989	K895873	CALCIUM, CATALOGUE NUMBER140-20	CJY	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
September 2, 1988	K875285	MULTI-CHEMISTRY LINEARITY STANDARD	JIX	Substantially Equivalent	Verichem Laboratories, Inc.	accessdata.fda.gov
August 30, 1988	K882258	DC-LIQUICAL CATALOGUE #SE-030	JIX	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
April 18, 1988	K875211	GLUCOSE (TRINDER) CAT. # 220-32	CGA	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
April 21, 1986	K861094	BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02	CIG	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
September 7, 1984	K843104	ALBUMIN ASSAY KIT	CIX	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
August 27, 1984	K843028	TOTAL PROTEIN ASSAY KIT	CEK	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov
August 17, 1984	K842160	CHOLESTEROL ASSSAY KIT	CHH	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 29, 2016	75818	Class II	Terminated	Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma	Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.	accessdata.fda.gov
January 22, 2016	73129	Class II	Terminated	Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of	Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover	accessdata.fda.gov
November 10, 2010	57230	Not yet classified	Terminated	Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.	Cholesterol Reagent bottles labels reversed for R1 and R2	accessdata.fda.gov
February 12, 2009	51156	Not yet classified	Terminated	DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.	Labeled with extended expiration date (24 months instead of 18 months)	accessdata.fda.gov
March 14, 2008	47475	Not yet classified	Terminated	Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.	Precipitate in product may cause elevated background absorbance interference.	accessdata.fda.gov
December 5, 2006	37011	Not yet classified	Terminated	Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892	Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories	accessdata.fda.gov
September 6, 2006	36864	Not yet classified	Terminated	Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252	Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct	accessdata.fda.gov

Compare with other makers

Updated February 18, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.