|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||ORTHO-CLINICAL DIAGNOSTICS, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modifications to the component parts of the luminometer signal processor board (lspb). The lspb is used on the vitros eci/eciq immunodiagnostic system, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system.