PMA P990041S005
- Device
- DIASORIN ETI-AB-EBK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990041
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2004-03-26
- 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 QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI-AB-EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA.
Current openFDA PMA Record#
- Device
- DIASORIN ETI-AB-EBK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990041
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2004-03-26
- Decision code
- OK30
- Date received
- 2004-03-11
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI-AB-EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA.