PMA P080027S016
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S016
- Product code
- MZO
- Decision date
- 2014-07-11
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THECOMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB).
Current openFDA PMA Record#
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S016
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2014-07-11
- Decision code
- APPR
- Date received
- 2014-03-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THECOMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB).