PMA P990038S004
- Device
- DIASORIN HBSAG CONFIRMATORY TEST
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2003-03-14
- 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
- APPROVAL FOR USE OF A DIASORIN HBSAG CONFIRMATORY REAGENT TO CONFIRM ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES, AND USE OF A DIASORIN CONFIRMATORY REAGENT SPECIFICALLY IN PRENATAL SCREENING TO CONFIRM ALL ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES IN THE ABSENCE OF OTHER HBV MARKER TESTING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIASORIN HBSAG CONFIRMATORY TEST AND IS INDICATED FOR AN IN VITRO NEUTRALIZATION ASSAY FOR QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA SAMPLES (EDTA, HEPARIN, AND CITRATE) FOUND TO BE REPEATEDLY REACTIVE FOR HBSAG BY ETI-MAK-2 PLUS. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.
Current openFDA PMA Record#
- Device
- DIASORIN HBSAG CONFIRMATORY TEST
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2003-03-14
- Decision code
- APPR
- Date received
- 2002-10-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USE OF A DIASORIN HBSAG CONFIRMATORY REAGENT TO CONFIRM ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES, AND USE OF A DIASORIN CONFIRMATORY REAGENT SPECIFICALLY IN PRENATAL SCREENING TO CONFIRM ALL ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES IN THE ABSENCE OF OTHER HBV MARKER TESTING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIASORIN HBSAG CONFIRMATORY TEST AND IS INDICATED FOR AN IN VITRO NEUTRALIZATION ASSAY FOR QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA SAMPLES (EDTA, HEPARIN, AND CITRATE) FOUND TO BE REPEATEDLY REACTIVE FOR HBSAG BY ETI-MAK-2 PLUS. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.