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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 HBSAG TEST SYSTEM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990012
Supplement NumberS006
Date Received04/30/2008
Decision Date10/30/2008
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend application of the elecsys hbsag and elecsys anti-hbs test systems onto the updated version of the modular analytics e170 analyzer known as the cobas e 601 analyzer. While the modular analytics modular system integrates the e170 module with clinical chemistry modules p or d, the cobas e 601 immunoassay analyzer is a component of the c6000 modular system which integrates immunology testing with the cobas c 501 clinical chemistry analyser. There have been no changes to the composition of any of te test system reagents (immunoassay, controls or confirmatory test), the application parameters, the analyzer¿s analytical measuring component or how the results are calculated. The indications for use of the two test systems remain the same.
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