|
Device | DIASORIN 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 | S007 |
Date Received | 10/17/2002 |
Decision Date | 11/08/2002 |
Reclassified Date
|
02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION. |