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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.
 
DeviceACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd m/s
w-110
brea, CA 92822
PMA NumberP850048
Supplement NumberS024
Date Received01/10/2011
Decision Date02/07/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the following new warning label to all access dxi systems. ¿warning¿ erroneous results can occur if reagent packs are not loaded properly. 1) never transfer a partial reagent pack that was used on a different system. 2) always load a reagent pack before scanning the bar code (access/access 2 only). For specific instructions, consult the system documentation.
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