FDA device listing
ELECSYS FOLATE GEN 3 CALCHECK KIT,Elecsys Folate gen 3 products,Elecsys Folate III,Elecsys Folate III CalCheck,Elecsys…
FDA device listing 2020867859 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | ELECSYS FOLATE GEN 3 CALCHECK KIT,Elecsys Folate gen 3 products,Elecsys Folate III,Elecsys Folate III CalCheck,Elecsys Folate III CalSet,Elecsys PreciControl Anemia,Elecsys RBC Folate Hemolysing Reagent,Folate G3 CC 3 Elecsys,Folate G3 CS Elecsys V2 |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K082340 |
| Product codes | CGN, JIT, JJX, JJY |
| Device names | CGN - Acid, Folic, Radioimmunoassay, JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1295, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIAGNOSTICS GMBH |
| Establishment registrations | 9610126, 9610529 |
| FEI numbers | 3002806559, 3002806560 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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