|
Device | AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS |
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 | S006 |
Date Received | 10/05/2000 |
Decision Date | 02/02/2001 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN PURIFICATION PROCESS AND STORAGE CONDITIONS OF COMPONENTS OF THE AB-HAVK RIA DEVICE AND THE ETI-AB-HAVK PLUS DEVICE. |