|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||ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||ROCHE DIAGNOSTICS CORP.|
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a transfer of a portion of the manufacturing operations for the bulk solutions of reagents r1 and r2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.