FDA Registration
Active
🇨🇦 Canada
Sekisui Diagnostics P.E.I. Inc.
Reg #: 8020316
·
FEI: 3002806809
·
Expires 2026
Products
47
Proprietary Names
79
Establishment Types
4
Classifications
47
Registration Details
- Registration Name
- Sekisui Diagnostics P.E.I. Inc.
- Registration Number
- 8020316
- FEI Number
- 3002806809
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 70 Watts Avenue
- City
- CHARLOTTETOWN Prince Edward Island
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K973999
Owner / Operator
- Firm Name
- Sekisui Diagnostics, LLC
- Operator Number
- 10035388
- Address
- 6659 Top Gun Street
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
US Agent
- Business Name
- Sekisui Diagnostics, LLC
- Contact Name
- Jason Bilobram
- Address
- 6659 Top Gun St
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 781 6527848
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2012-02-01 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2012-02-01 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2012-02-01 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2012-02-01 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2024-05-15 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-09-19 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2013-02-01 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2011-02-25 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2011-02-25 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2018-08-09 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2014-01-28 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2014-01-28 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2011-02-25 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2011-02-24 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2011-02-24 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2011-02-24 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2024-05-15 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2024-05-15 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2020-01-14 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2011-02-24 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2011-03-21 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2013-02-01 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2011-02-24 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2015-07-24 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2015-07-24 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2018-06-28 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2013-05-07 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2011-02-24 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2011-12-23 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2011-02-25 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2011-02-25 |
Proprietary Names
Creatine Kinase Assay
Creatine Kinase SL
Total Protein
Microalbumin Multicalibrator Set
DC Cal Calibrators
HbA1c Controls
Acetaminophen Cal
Acetaminophen
Acetaminophen SL
Salicylate Cal
Salicylate
Salicylate SL
Uric Acid Assay
Carbon Dioxide L3K C
Microalbumin Assay
Gamma Glutamyltranspepidase
Gamma Glutamyltranspepidase L3K
Liquid N-Geneous HDL Cholesterol Kit/ Cal
Amylase Assay
Liquid Select Amylase Reagent
a-Amylase Test Reagent
Aspartate Amino Transferase SL
Calcium Assay
Iron SL
Creatinine-S Assay
DC Trols Levels 1 and 2
N-Geneous LDL-ST Reagent & Calibrator
Direct Bilirubin
ALT-SL
N-Geneous LDL Cholesterol Calibrator
N-Geneous LDL Cholesterol Reagent
LDL Direct Liquid Select Cholesterol Reagent
Albumin Assay
Phosphorous SL
Magnesium
Unsaturated Iron Binding Complex
UIBC-SL
Acetaminophen L3K Assay
Acetaminophen Assay
Ammonia L3K
Glucose SL C
Magnesium Assay
Magnesium Reagent
Iron PC SL
Triglyceride
Lipase color calibrator
CRP Ultra Wide Range Reagent
Ultra Sensitive Calibrator
Ultra N-Geneous HDL Cholesterol Reagent & Calibrator
HDL Ultra Cholesterol Reagent
Uric Acid SL
Cholesterol Assay
Cholesterol SL
Carbon Dioxide Standard
Urea L3K
HbA1c Blank Solution
HbA1c Calibrators
Enzymatic Creatinine
Total Bilirubin SL X
Lactate Dehydrogenase Assay
Lactate Dehydrogenase
Alanine Amino Transferase L3K
Alanine Amino Transferase-SL
Lipase Color Calibrator
Lipase Color Solvent
Lipase Color Activator
Lipase Color Reagent
Glucose SL
Total Bilirubin SL
GGT Assay
DC-UIBC-Cal Calibrator
Ammonia Assay
Acetaminophen L3K
Carbon Dioxide L3K
Direct Bilirubin SL
DC-UIBC Lineate
Glucose
Alkaline Phosphatase SL
Ethanol L3K
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device