FDA device listing
AST 1100Tests cobas c 701,CARB, 200Tests, cobas Integra,CK-MB 100T c111,cobas c 70X Iron/750,cobas c 70X…
FDA device listing 1448151041 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | AST 1100Tests cobas c 701,CARB, 200Tests, cobas Integra,CK-MB 100T c111,cobas c 70X Iron/750,cobas c 70X Phosphorus/600,cobas c 70X Total Protein/700,cobas C ASTL/PYP,cobas C INTEGRA FRUC,cobas Integra 400 Plus,cobas INTEGRA 400 Plus,cobas INTEGRA ALANINE TRANSAMINASE 500,COBAS INTEGRA ANALYZER PRODUCTS,cobas INTEGRA ASPARTATE TRANSAMINASE 500,cobas INTEGRA BENZODIAZEPINES 200,cobas INTEGRA… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K951595 |
| Product codes | CDQ, CDT, CEK, CEO, CET, CFN, CFR, CGX, CGZ, CHH, CIC, CIG and 50 more |
| Device names | CDQ - Urease And Glutamic Dehydrogenase, Urea Nitrogen, CDT - Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, CEK - Biuret (Colorimetric), Total Protein, CEO - Phosphomolybdate (Colorimetric), Inorganic Phosphorus, CET - Olive Oil Emulsion (Turbidimetric), Lipase, CFN - Method, Nephelometric, Immunoglobulins (G, A, M), CFR - Hexokinase, Glucose, CGX - Alkaline Picrate, Colorimetry, Creatinine, CGZ - Electrode, Ion-Specific, Chloride, CHH - Enzymatic Esterase--Oxidase, Cholesterol, CIC - Cresolphthalein Complexone, Calcium, CIG - Diazo Colorimetry, Bilirubin and 50 more |
| Device class | Class I, Class II, Unclassified |
| Classification regulations (21 CFR) | 862.1030, 862.1035, 862.1050, 862.1070, 862.1100, 862.1110, 862.1145, 862.1150, 862.1170, 862.1175, 862.1215, 862.1225 and 40 more |
| Review panels | Clinical Chemistry, Clinical Toxicology, Hematology, Immunology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, ROCHE DIAGNOSTICS INTERNATIONAL LTD. |
| Establishment registrations | 9610126, 9610529, 3003795116 |
| FEI numbers | 3002806559, 3002806560, 3003795116 |
| Establishment operations | Foreign Exporter, 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