FDA device listing
GEM Premier 7000 with iQM3,GEM Premier 7000 with iQM3 PAK
FDA device listing 1221365479 · Instrumentation Laboratory Co.
Key facts
| Proprietary names | GEM Premier 7000 with iQM3,GEM Premier 7000 with iQM3 PAK |
|---|---|
| Owner/operator | Instrumentation Laboratory Co. |
| Owner/operator number | 1217183 |
| Premarket submissions | K223608 |
| Product codes | CEM, CGA, CGZ, CHL, GHS, GKF, GKR, GLY, JFP, JGS, KHP, MQM |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGA - Glucose Oxidase, Glucose, CGZ - Electrode, Ion-Specific, Chloride, CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, GHS - Assay, Carboxyhemoglobin, GKF - Instrument, Hematocrit, Automated, GKR - System, Hemoglobin, Automated, GLY - Oximeter To Measure Hemoglobin, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, KHP - Acid, Lactic, Enzymatic Method, MQM - Bilirubin (Total And Unbound) In The Neonate Test System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1113, 862.1120, 862.1145, 862.1170, 862.1345, 862.1450, 862.1600, 862.1665, 864.5600, 864.5620, 864.7425, 864.7500 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | INSTRUMENTATION LABORATORY CO., INSTRUMENTATION LABORATORY CO. - Devens |
| Establishment registrations | 1217183, 2431530, 3037000637 |
| FEI numbers | 1217183, 2431530, 3037000637 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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