Sekisui Diagnostics P.E.I. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Sekisui Diagnostics P.E.I. Inc. appears in FDA device records in CHARLOTTETOWN Prince Edward Island, CA. FDA records list 72 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Sekisui Diagnostics P.E.I. Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Diagnostic Chemicals , Ltd.510(k), recall
510(k) clearance history
Showing 50 of 72FDA records hold 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc. between 1994 and 2022. The busiest year on record is 1998, with 14. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 10 |
| 1997 | 7 |
| 1998 | 14 |
| 1999 | 2 |
| 2000 | 8 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 8 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 2 |
| 2011 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202644 | Acetaminophen | LDP | Substantially Equivalent | |
| K182702 | SEKURE Creatine Kinase Assay | CGS | Substantially Equivalent | |
| K180835 | SEKURE Acetaminophen L3K Assay | LDP | Substantially Equivalent | |
| K173206 | SEKURE HbA1c Assay | PDJ | Substantially Equivalent | |
| K163078 | DC-UIBC-CAL | JIT | Substantially Equivalent | |
| K111915 | MAGNESIUM ASSAY | JGJ | Substantially Equivalent | |
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | JFY | Substantially Equivalent | |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | JGJ | Substantially Equivalent | |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | DCK | Substantially Equivalent | |
| K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 | JIT | Substantially Equivalent | |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | CJY | Substantially Equivalent | |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | DCF | Substantially Equivalent | |
| K042330 | ACETAMINOPHEN-SL ASSAY | LDP | Substantially Equivalent | |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 | KHS | Substantially Equivalent | |
| K042329 | SALICYLATE-SL ASSAY | DKJ | Substantially Equivalent | |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | LBS | Substantially Equivalent | |
| K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | MRR | Substantially Equivalent | |
| K041926 | HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 | JIX | Substantially Equivalent | |
| K042243 | MICROALBUMIN MULTI-CALIBRATOR SET | JIX | Substantially Equivalent | |
| K041666 | DC-ACETA/SAL CONTROLS | DIF | Substantially Equivalent | |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | JIF | Substantially Equivalent | |
| K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 | CFR | Substantially Equivalent | |
| K023330 | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 | CIG | Substantially Equivalent | |
| K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | JIY | Substantially Equivalent | |
| K013178 | DC-UIBC-CO2-CAL, MODEL SE-153 | JIX | Substantially Equivalent | |
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | CJE | Substantially Equivalent | |
| K002354 | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 | KHS | Substantially Equivalent | |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | CDQ | Substantially Equivalent | |
| K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | DIC | Substantially Equivalent | |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | JIF | Substantially Equivalent | |
| K000055 | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 | CGX | Substantially Equivalent | |
| K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | JIR | Substantially Equivalent | |
| K993920 | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 | DIC | Substantially Equivalent | |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | CDQ | Substantially Equivalent | |
| K990754 | CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 | KHS | Substantially Equivalent | |
| K983019 | CARBON DIOXIDE-SL ASSAY, CAT # 253-01 | KHS | Substantially Equivalent | |
| K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | DKJ | Substantially Equivalent | |
| K981609 | BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 | CIG | Substantially Equivalent | |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | LDP | Substantially Equivalent | |
| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | LBR | Substantially Equivalent | |
| K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | LBR | Substantially Equivalent | |
| K974002 | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 | DIC | Substantially Equivalent | |
| K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | CGS | Substantially Equivalent | |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | LDP | Substantially Equivalent | |
| K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | DKJ | Substantially Equivalent | |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | CEK | Substantially Equivalent | |
| K980316 | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 | CJE | Substantially Equivalent | |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | CEO | Substantially Equivalent | |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | CFJ | Substantially Equivalent | |
| K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 | JFJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8020316 | 3002806809 | Sekisui Diagnostics P.E.I. Inc. | 70 Watts Avenue, CHARLOTTETOWN Prince Edward Island C1E 2B9 CA | 2026 | and 37 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride
- KNKAcid, Uric, Uricase (Colorimetric)
- DCFAlbumin, Antigen, Antiserum, Control
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- JFJCatalytic Methods, Amylase
- LDPColorimetry, Acetaminophen
- DIHColorimetry, Cholinesterase
- DKJColorimetry, Salicylate
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JIFEnzymatic Method, Ammonia
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CGAGlucose Oxidase, Glucose
- PDJHemoglobin A1c Test System
- CFRHexokinase, Glucose
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- MRRSystem, Test, Low Density, Lipoprotein
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1078-2017 | 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. | Class II | Terminated | |
| Z-1171-2016 | 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 Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity. | Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover | Class II | Terminated | |
| Z-0711-2011 | 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 | Terminated | ||
| Z-2327-2009 | DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP. | Labeled with extended expiration date (24 months instead of 18 months) | Terminated | ||
| Z-2326-2009 | 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) | Terminated | ||
| Z-1327-2009 | 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. | Terminated | ||
| Z-0361-2007 | 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 | Terminated | ||
| Z-0536-2007 | 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 | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Sekisui Diagnostics P.E.I. Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain