|
Device | DIASORIN ETI-AB-HAVK PLUS ASSAY |
Generic Name | Hepatitis a test (antibody and igm antibody) |
Regulation Number | 866.3310 |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE PO BOX 285 STILLWATER, MN 55082-0285 |
PMA Number | P890019 |
Supplement Number | S009 |
Date Received | 01/30/2004 |
Decision Date | 02/20/2004 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
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." |