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 | ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P010054 |
Supplement Number | S002 |
Date Received | 09/15/2005 |
Decision Date | 10/06/2005 |
Product Code |
LOM |
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 CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS. |
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