PMA P990038S005
- Device
- DIASORIN ETI-MAK-2 PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2003-08-20
- 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 A REVISION IN THE ASSAY PACKAGE INSERT THAT INCORPORATES A CHANGE IN THE INTERPRETATION ALGORITHM FOR REPEAT TESTING RESULTS THAT MAKE IT THE SAME AS THE INTERPRETATION FOR INITIAL TESTING. "THE USER SHOULD APPLY THE SAME INTERPRETATION OF RESULTS (I.E. REACTIVE SAMPLES SHOULD HAVE AN ABSORBANCE VALUE GREATER THAN 90% OF THE CUTOFF) WHEN INITIAL TESTING FOR SOME SAMPLES AND REPEAT TESTING FOR OTHER SAMPLES ARE PERFORMED ON THE SAME PLATE."
Current openFDA PMA Record#
- Device
- DIASORIN ETI-MAK-2 PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2003-08-20
- Decision code
- APPR
- Date received
- 2003-07-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A REVISION IN THE ASSAY PACKAGE INSERT THAT INCORPORATES A CHANGE IN THE INTERPRETATION ALGORITHM FOR REPEAT TESTING RESULTS THAT MAKE IT THE SAME AS THE INTERPRETATION FOR INITIAL TESTING. "THE USER SHOULD APPLY THE SAME INTERPRETATION OF RESULTS (I.E. REACTIVE SAMPLES SHOULD HAVE AN ABSORBANCE VALUE GREATER THAN 90% OF THE CUTOFF) WHEN INITIAL TESTING FOR SOME SAMPLES AND REPEAT TESTING FOR OTHER SAMPLES ARE PERFORMED ON THE SAME PLATE."