FDA device listing
Chemstrip 10,Chemstrip 10 SG 100 Str.,Chemstrip 10 UA 100 Str.,Chemstrip 10 w/SG,Chemstrip 2 GP,Chemstrip 2 GP 100 Str…
FDA device listing 1256823013 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Chemstrip 10,Chemstrip 10 SG 100 Str.,Chemstrip 10 UA 100 Str.,Chemstrip 10 w/SG,Chemstrip 2 GP,Chemstrip 2 GP 100 Str. 1 St,Chemstrip 2 LN 100 Str. |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K896454 |
| Product codes | CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, 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, 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, 864.6550, 864.7675 |
| Review panels | Clinical Chemistry, Hematology |
| 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
- 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