GRAS Notices
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GRN No. 435
Preparation consisting of six bacterial monophage specific to Salmonella enterica (monophage cocktail)
| Intended Use: | Intended for use as an antimicrobial in certain poultry products, fish, shellfish, and fresh and processed fruits and vegetables; raw poultry in general; and ready-to-eat and raw red meat carcasses, subprimals and trimmings at up to 108 PFU/g of food; for use as an antimicrobial at up to 108 PFU/g of food in grain and grain products. |
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| Basis: | Scientific procedures |
| Notifier: | Intralytix, Inc. |
| Notifier Address: |
701 E. Pratt Street Baltimore, MD 21202 |
| Date of filing: | Jul 6, 2012 |
| GRAS Notice (releasable information): | GRN 435 (in PDF) (7.5 MB) |
| Date of closure: | Feb 22, 2013 |
| FDA's Letter: | FDA has no questions |
| Additional correspondence: | Feb 13, 2015 |
| Additional correspondence regarding an additional intended use | |
| Additional correspondence: | Nov 15, 2019 |
| Supplemental Letter (in PDF) (74 kB) | |
| Additional correspondence: | Jun 28, 2021 |
| Supplemental Letter (in PDF) (235 kB) | |
| Additional correspondence: | Jan 17, 2024 |
| Supplemental Letter (in PDF) (220 kB) |
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