FDA device listing
cobas e-ELECSYS FREE PSA GEN.2,Elecsys free PSA,Elecsys free PSA Test System,free PSA CalCheck,Free PSA CalCheck,free…
FDA device listing 1756106859 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas e-ELECSYS FREE PSA GEN.2,Elecsys free PSA,Elecsys free PSA Test System,free PSA CalCheck,Free PSA CalCheck,free PSA CalSet,FREE PSA CALSET,Free PSA CC 3 Elecsys,free PSA CS Elecsys V2,free PSA CS Elecsys V3,free PSA Elecsys cobas e 100 V2,free PSA Elecsys cobas e 100 V3,free PSA Elecsys E2G 100 V2,free PSA Elecsys E2G 300,free PSA Elecsys E2G 300 V2,free PSA Gen.2 Elecsys,cobas e |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | P000027 |
| Product codes | LTJ, MTG |
| Device names | LTJ - Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, MTG - Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 866.6010, ORCA1.MTG |
| Review panels | Immunology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH |
| Establishment registrations | 9610126 |
| FEI numbers | 3002806559 |
| Establishment operations | Manufacturer |
| 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