| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER |
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| Classification Name | assay,enzyme linked immunosorbent,hepatitis c virus |
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| Applicant | ROCHE DIAGNOSTICS CORP. |
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| PMA Number | P090007 |
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| Date Received | 05/15/2009 |
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| Decision Date | 04/29/2010 |
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| Product Code | |
| Docket Number | 10M-0261 |
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| Notice Date | 06/14/2010 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the elecsys anti-hcv immunoassay & elecsys precicontrol anti-hcv assay for use on cobas e 411 immunoassay analyzer. This device is indicated for: elecsys anti-hcv immunoassay the roche elecsys anti-hcv assay is an in vitro diagnostic test for the qualitative detection of total antibodies to hepatitis c virus (anti-hcv) in human serum or plasma (potassium edta, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hcv infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. The test does not determine the state of infection or associated disease. The electrochemilumi-nescence immunoassay "eclia" is intended for use on the cobas e 411 immunoassay analyzer. Elecsys precicontrol anti-hcv elecsys precicontrol anti-hcv is used for quality control of the elecsys anti-hcv immunoassay on the cobas e 411 immunoassay analyzer. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S010 S011 |
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