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 | QUANTIFERON -TB GOLD |
Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
Applicant | QIAGEN 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P010033 |
Supplement Number | S019 |
Date Received | 08/04/2011 |
Decision Date | 10/20/2011 |
Product Code |
NCD |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING: INSTRUCTIONS FOR USE SECTION, SPECIMEN COLLECTION AND HANDLING SECTION, AND ABBREVIATED TEST PROCEDURE SECTION FOR USE OF THE QUANTIFERON® BLOOD COLLECTION TUBES. |
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