PMA P890019S009
- Device
- DIASORIN ETI-AB-HAVK PLUS ASSAY
- Applicant
- Diasorin
- PMA number
- P890019
- Supplement
- S009
- Product code
- LOL
- Decision date
- 2004-02-20
- Classification
- Microbiology
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
Current openFDA PMA Record#
- Device
- DIASORIN ETI-AB-HAVK PLUS ASSAY
- Applicant
- Diasorin
- PMA number
- P890019
- Supplement
- S009
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2004-02-20
- Decision code
- APPR
- Date received
- 2004-01-30
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."