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AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEA,COBAS AMPLICOR CT/NG TEST FOR NG
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| Company Name | ROCHE MOLECULAR SYSTEMS, INC. |
| Address | 11 FRANKLIN AVE. |
| City, State, Zip | BELLEVILLE, NJ 07109 |
| Country | US |
| FDA Owner/Operator Phone | 925-730-8110 |
| FDA Medical Specialty Code | MI - Microbiology |
| FDA Product Code | LSL |
| FDA Classification Name | DNA-REAGENTS, NEISSERIA |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.3390 |
| FDA Common Generic Name | VARIOUS NEISSERIA GONORRHOEA TESTS, GONORRHOEA SEROLOGICAL REAGENTS |
| FDA Proprietary Device Name | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEA,COBAS AMPLICOR CT/NG TEST FOR NG |
| FDA Owner / Operator Number | 2243471 |
| FDA Owner / Operator Name | ROCHE MOLECULAR SYSTEMS, INC. |
| FDA Establishment Registration Number | 2247632 |
| FDA Registered Establishment Name | ROCHE MOLECULAR SYSTEMS, INC. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 08-04-03 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ROCHE MOLECULAR SYSTEMS, INC.
Our records indicate that the following medical device companies may manufacture a similar device.
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