PMA P990043S014
- Device
- ETI-EBK PLUS KIT
- Applicant
- DiaSorin, Inc.
- PMA number
- P990043
- Supplement
- S014
- Product code
- LOM
- Decision date
- 2011-09-16
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- USE OF AN ADDITIONAL VENDOR OF CHROMOGEN/SUBSTRATE BULK SOLUTION TO MANUFACTURE THE FINAL CHROMOGEN/SUBSTRATE REAGENT FOR THE ETI-EBK PLUS KIT. THE STABILITY DATA FOR THE NEW VENDOR'S CHROMOGEN/ SUBSTRATE REAGENT USING THE APPROVED PROTOCOL SUPPORTS AN EXPIRATION DATE OF 16 MONTHS.
Current openFDA PMA Record#
- Device
- ETI-EBK PLUS KIT
- Applicant
- DiaSorin, Inc.
- PMA number
- P990043
- Supplement
- S014
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-09-16
- Decision code
- OK30
- Date received
- 2011-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ADDITIONAL VENDOR OF CHROMOGEN/SUBSTRATE BULK SOLUTION TO MANUFACTURE THE FINAL CHROMOGEN/SUBSTRATE REAGENT FOR THE ETI-EBK PLUS KIT. THE STABILITY DATA FOR THE NEW VENDOR'S CHROMOGEN/ SUBSTRATE REAGENT USING THE APPROVED PROTOCOL SUPPORTS AN EXPIRATION DATE OF 16 MONTHS.