- Device
- HOME ACCESS HEPATITIS C TEST SERVICE
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S005
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2002-12-06
- Decision code
- APPR
- Date received
- 2002-10-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A REDUCTION OF A SUPPLEMENT TESTING RANGE (STR) FROM SPECIMENS WITH A SIGNAL-TO-CUTOFF VALUE FROM 5.0 TO 4.2.