MODIFICATION
A -- Anthrax Serology Test
- Notice Date
- 5/14/2002
- Notice Type
- Modification
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2002-N-00414
- Response Due
- 7/8/2002
- Archive Date
- 7/3/2002
- Point of Contact
- Lynn Walling, Contract Specialist, Phone 770-488-2612, Fax 770-488-2777,
- E-Mail Address
-
lqw5@cdc.gov
- Description
- This project is entitled "Anthrax Serology Test". The purpose of this project is to (1) test and validate CDC's ELISA test under quality standardized reagent (QSR) guidelines and generate appropriate documentation for seeking FDA 510-K approval; (2) develop an Anthrax assay that discriminates IgM and IgG antibodies, using Western Blot or CDC approved equivalent and incorporating native/recombinant antigens directed at epitopes that will permit distinction between vaccinated and non-vaccinated individuals; (3) submit CDC's anthrax ELISA test and the WB or CDC approved equivalent test as a kit for FDA 510-K approval; and (4) commercialize the FDA 510-K approved anthrax assay kit. The performance period is 12 months. All questions/concerns shall be submitted via E-MAIL to lqw5@cdc.gov. When sending your request via e-mail state your name, company name and complete address, phone/fax number and e-mail address. The tentative issue date is May 29, 2002, and will be available for viewing and download for submission of a proposal.
- Record
- SN00076620-W 20020516/020514213252 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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