PMA P990044S004
- Device
- DIASORIN ETI-CORE-IGMK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2003-05-07
- 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 QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-CORE-IGMK PLUS.
Current openFDA PMA Record#
- Device
- DIASORIN ETI-CORE-IGMK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2003-05-07
- Decision code
- OK30
- Date received
- 2003-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-CORE-IGMK PLUS.