Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER |
Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
Regulation Number | 866.6010 |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P820060 |
Supplement Number | S016 |
Date Received | 11/26/2002 |
Decision Date | 02/02/2004 |
Withdrawal Date
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11/15/2013 |
Product Code |
LOJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF THE ABBOTT ARCHITECT AFP ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT ARCHITECT AFP ASSAY FOR THE ARCHITECT I2000 ANALYZER AND IS INDICATED FOR THE FOLLOWING: 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER. 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF OPEN NEURAL TUBE DEFECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD. |
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