FDA device listing
Chemstrip 10 UA,cobas u411,COBAS U411 TEST SYSTEM,cobas u 411 Urine Analyzer
FDA device listing 1802366463 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Chemstrip 10 UA,cobas u411,COBAS U411 TEST SYSTEM,cobas u 411 Urine Analyzer |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K093555 |
| Product codes | CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, KQO, LJX |
| Device names | CDM - Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), CEN - Dye-Indicator, Ph (Urinary, Non-Quantitative), JIL - Method, Enzymatic, Glucose (Urinary, Non-Quantitative), JIN - Nitroprusside, Ketones (Urinary, Non-Quant.), JIO - Blood, Occult, Colorimetric, In Urine, JIR - Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), JJB - Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.), JMT - Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), JRE - Refractometer For Clinical Use, KQO - Automated Urinalysis System, LJX - Test, Urine Leukocyte |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1115, 862.1340, 862.1435, 862.1510, 862.1550, 862.1645, 862.1785, 862.2800, 862.2900, 864.6550, 864.7675 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, ROCHE DIAGNOSTICS INTERNATIONAL LTD. |
| Establishment registrations | 9610126, 3003795116 |
| FEI numbers | 3002806559, 3003795116 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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