PMA P990044S012
- Device
- ETI-CORE-IGMK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S012
- Product code
- LOM
- Decision date
- 2012-03-09
- 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 QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
Current openFDA PMA Record#
- Device
- ETI-CORE-IGMK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S012
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-03-09
- Decision code
- OK30
- Date received
- 2012-02-17
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.