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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameimmunoassay for antibody t hepatitis b surface antigen; anti-hbs control reagents
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP010054
Supplement NumberS002
Date Received09/15/2005
Decision Date10/06/2005
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change in quality controls that add a new specification, or otherwise provide additional assurance of purity, identity, strength, or reliability of the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs.
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