FDA device listing
ION SPECIFIC,i-STAT CHEM8+ Cartridge,I-STAT TC02 TEST,I-STAT TCO2 TEST
FDA device listing 1518613718 · ABBOTT LABORATORIES
Key facts
| Proprietary names | ION SPECIFIC,i-STAT CHEM8+ Cartridge,I-STAT TC02 TEST,I-STAT TCO2 TEST |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K053110 |
| Product codes | CDS, CEM, CGA, CGL, CGZ, JFL, JFP, JGS, JPI |
| Device names | CDS - Electrode, Ion Specific, Urea Nitrogen, CEM - Electrode, Ion Specific, Potassium, CGA - Glucose Oxidase, Glucose, CGL - Electrode, Ion Based, Enzymatic, Creatinine, CGZ - Electrode, Ion-Specific, Chloride, JFL - Ph Rate Measurement, Carbon-Dioxide, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, JPI - Device, Hematocrit Measuring |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1145, 862.1160, 862.1170, 862.1225, 862.1345, 862.1600, 862.1665, 862.1770, 864.6400 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | ABBOTT POINT OF CARE CANADA LIMITED |
| Establishment registrations | 3005643513 |
| FEI numbers | 3005643513 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database