PMA P080027S001
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S001
- Product code
- MZO
- Decision date
- 2011-02-18
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR THE ORAQUICK HCV RAPID ANTIBODY TEST IS A SINGLE-USE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN FINGERSTICK WHOLE BLOOD SPECIMENS AND VENIPUNCTURE WHOLE BLOOD SPECIMENS (EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, AND SODIUM CITRATE) FROM INDIVIDUALS 15 YEARS OR OLDER. THE ORAQUICK HCV RAPID ANTIBODY TEST RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080027S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S001
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-02-18
- Decision code
- APPR
- Date received
- 2010-08-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ORAQUICK HCV RAPID ANTIBODY TEST IS A SINGLE-USE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN FINGERSTICK WHOLE BLOOD SPECIMENS AND VENIPUNCTURE WHOLE BLOOD SPECIMENS (EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, AND SODIUM CITRATE) FROM INDIVIDUALS 15 YEARS OR OLDER. THE ORAQUICK HCV RAPID ANTIBODY TEST RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.