PMA P990045S003
- Device
- ETI-AB-COREK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2002-11-08
- 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
- CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
Current openFDA PMA Record#
- Device
- ETI-AB-COREK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2002-11-08
- Decision code
- OK30
- Date received
- 2002-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.