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FUJIREBIO DIAGNOSTICS CA 19-9 RIA
 Request for Information Form |
 Contact Information
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| Company Name | FUJIREBIO DIAGNOSTICS, INC. |
| Address | 201 GREAT VALLEY PKWY. |
| City, State, Zip | MALVERN, PA 19355 |
| Country | US |
| FDA Owner/Operator Phone | -- |
| 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 | IMMUNOLOGICAL TEST FOR 1116N519-9 ANTIBODY DEFINED ANTIGEN (CA19-9) |
| FDA Proprietary Device Name | FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
| FDA Owner / Operator Number | 8031611 |
| FDA Owner / Operator Name | FUJIREBIO DIAGNOSTICS, INC. |
| FDA Establishment Registration Number | 2521625 |
| FDA Registered Establishment Name | FUJIREBIO DIAGNOSTICS, INC. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 05-28-02 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of FUJIREBIO DIAGNOSTICS, INC.
Our records indicate that the following medical device companies may manufacture a similar device.
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