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ELECSYS CA 19-9
 Request for Information Form |
 Contact Information
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| Company Name | ROCHE DIAGNOSTICS GMBH |
| Address | NONNENWALD 2 |
| City, State, Zip | PENZBERG, |
| Country | GM |
| FDA Owner/Operator Phone | 49-621-7670 |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | NIG |
| FDA Classification Name | SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.6010 |
| FDA Common Generic Name | IMMUNOASSAY-CANCER MARKER |
| FDA Proprietary Device Name | ELECSYS CA 19-9 |
| FDA Owner / Operator Number | 9036646 |
| FDA Owner / Operator Name | ROCHE DIAGNOSTICS GMBH MANNHEIM |
| FDA Establishment Registration Number | 9610529 |
| FDA Registered Establishment Name | ROCHE DIAGNOSTICS GMBH |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 07-11-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ROCHE DIAGNOSTICS GMBH
Our records indicate that the following medical device companies may manufacture a similar device.
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