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Device | QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE |
Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
Applicant | QIAGEN 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P010033 |
Date Received | 06/01/2001 |
Decision Date | 11/28/2001 |
Product Code |
NCD |
Docket Number | 02M-0218 |
Notice Date | 05/13/2002 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE CELLESTIS QUANTIFERON-TB. THE DEVICE IS INDICATED FOR USE AS AN AID IN THE DETECTION OF INFECTION WITH MYCOBACTERIUM TUBERCULOSIS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S023 S024 S025 S026 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 |