PMA P060031S005
- Device
- BIO-RAD MONOLISA ANTI-HBC EIA
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P060031
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2011-04-28
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE IN THE SCALE OF MANUFACTURE OF THE CONJUGATE REAGENT COMPONENT OF THE BIO-RAD MONOLISA ANTI-HBC EIA.
Current openFDA PMA Record#
- Device
- BIO-RAD MONOLISA ANTI-HBC EIA
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P060031
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-04-28
- Decision code
- OK30
- Date received
- 2011-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SCALE OF MANUFACTURE OF THE CONJUGATE REAGENT COMPONENT OF THE BIO-RAD MONOLISA ANTI-HBC EIA.