Abbott Point of Care Canada Limited
Ottawa Ontario, CA
ABBOTT POINT OF CARE CANADA LIMITED appears in FDA device records in Ottawa Ontario, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005643513 | 3005643513 | ABBOTT POINT OF CARE CANADA LIMITED | 185 CORKSTOWN ROAD, Ottawa Ontario K2H 8V4 CA | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- JBPActivated Whole Blood Clotting Time
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MYTBiosensor, Immunoassay, Cpk Or Isoenzymes
- QATBrain Trauma Assessment Test
- GLKControl, Hematocrit
- JPIDevice, Hematocrit Measuring
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGLElectrode, Ion Based, Enzymatic, Creatinine
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- JJRElectrolyte Controls (Assayed And Unassayed)
- CGAGlucose Oxidase, Glucose
- MMIImmunoassay Method, Troponin Subunit
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JFLPh Rate Measurement, Carbon-Dioxide
- GGNPlasma, Coagulation Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- NBCTest, Natriuretic Peptide
- GJSTest, Time, Prothrombin
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0716-2013 | Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality. | APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. | Class II | 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 Abbott Point of Care Canada Limited 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