PMA P990038S008
- Device
- DIASORIN ETI-MAK-2 PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S008
- Product code
- LOM
- Decision date
- 2004-05-19
- 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 MANUFACTURING MATERIALS USED TO PRODUCE THE ETI-MAK-2 PLUS TRACER DILUENT. THIS CHANGE WAS TO ADD INACTIVATED HORSERADISH PEROXIDASE, 2.5 MG/L, TO THE ETI-MAK-2 PLUS TRACER DILUENT.
Current openFDA PMA Record#
- Device
- DIASORIN ETI-MAK-2 PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2004-05-19
- Decision code
- OK30
- Date received
- 2004-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING MATERIALS USED TO PRODUCE THE ETI-MAK-2 PLUS TRACER DILUENT. THIS CHANGE WAS TO ADD INACTIVATED HORSERADISH PEROXIDASE, 2.5 MG/L, TO THE ETI-MAK-2 PLUS TRACER DILUENT.