Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P000044 |
Supplement Number | S002 |
Date Received | 05/29/2001 |
Decision Date | 06/18/2001 |
Product Code |
LOM |
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 TO THE ACCEPTANCE CRITERIA APPLIED TO THE TEST FOR HUMAN PLASMA USED AS A RAW MATERIAL IN THE FORMULATION OF ASSAY REAGENT, A COMPONENT OF THE VITROS HBSAG REAGENT PACK AND IN THE FORMULATION OF SAMPLE DILUENT, A COMPONENT OF THE VITROS HBASAG CONFIRMATORY KIT. |
|
|