| 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 | AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 |
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| Classification Name | assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
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| Applicant | ROCHE MOLECULAR SYSTEMS, INC. |
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| PMA Number | P000010 |
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| Date Received | 02/23/2000 |
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| Decision Date | 07/05/2001 |
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| Product Code | |
| Docket Number | 02M-0082 |
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| Notice Date | 02/27/2002 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | Yes |
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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 amplicor hepatitis c virus (hcv) test, v2. 0. The device is indicated for: the qualitative detection of hcv rna in human serum or plasma from blood collected in edta (edta plasma). The test detects by reverse-transcribing target hcv rna into cdna, amplifying cdna by polymerase chain reaction (pcr), hybridizing amplified cdna with an oligonucleotide probe that binds enzyme, and catalyzing conversion of substrate to a colored product that is recognized by a microwell plate reader. The amplicor hcv test, v2. 0 is indicated for patients who have evidence of liver disease and antibody evidence of hcv infection, and who are suspected to be actively infected with hcv. Detection of hcv rna indicates that the virus is replicating and therefore is evidence of active infection. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S003 S004 S005 S006 S007
S009 S010 S011 S012 S013 S014
S015 S016 S017 S018 S019 S020
S022 S023 S024 S025 |
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