Label: OSSAPIG-NF-NF1(FS41) MINIATURE SWINE (nf1 hindiii restriction fragment length polymorphism- rflp positive for nf1-r1947 stop codon in ossabaw breed swine not applicable
- NDC Code(s): 86086-002-01
- Packager: Recombinetics, Inc.
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated November 18, 2020
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STATEMENT OF IDENTITY
Identity: Transcription activator-like effector nuclease (TALEN) edit and homology dependent repair in Ossabaw breed porcine fetal fibroblasts to introduce a C>T base substitution at base pair 43,530,892 and insertion of five nucleotides between base pairs 43,308,890 and 43,530,889 of Sus scrofa chromosome 12 (NC_010454.4). The base substitution generates a premature stop codon in the coding sequence for the neurofibromin protein and the five nucleotide insertion generates a HindIII restriction enzyme site used to genotype progeny from gene edited founders.
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- INDICATIONS & USAGE
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INDICATIONS & USAGE
Conditions of Use: This model animal and any products derived from it are for biomedical research purposes only and not for use in humans. This is an investigational animal. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.
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WARNINGS AND PRECAUTIONS
Caution. This intentionally genetically altered animal and any products derived from it are for biomedical research purposes only and are not for use in humans or as human or animal food.
OssaPig-NF-NF1(FS41) animals are not for resale. No reproduction, distribution, transportation, or other third party transfer is allowed by the purchaser unless specifically agreed to in writing by Recombinetics, Inc.
OssaPig-NF-NF1(FS41) animals, or any materials derived from the OssaPig-NF-NF1(FS41) animals, are not intended to enter the human or animal food supply.
OssaPig-NF-NF1(FS41) animals shall be euthanized in accordance with all applicable regulatory or industry standards, and all animal remains must be disposed of by incineration. Purchaser must maintain detailed records accounting for the location of all OssaPig-NF-NF1(FS41) animals, and all materials derived from the OssaPig-NF-NF1(FS41) animals, from the time the animals are delivered to Purchaser through disposition by incineration. Final disposition notification must be made to Recombinetics, Inc. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OSSAPIG-NF-NF1(FS41) MINIATURE SWINE
nf1 hindiii restriction fragment length polymorphism (rflp) positive for nf1-r1947 stop codon in ossabaw breed swine not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86086-002 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA G.(NC_010454.4)43530892C>T + 43530890_43530889insAGCTT IN OSSABAW MINIATURE SWINE (UNII: FY9NU6D8JD) (SUS SCROFA G.(NC_010454.4)43530892C>T + 43530890_43530889insAGCTT IN OSSABAW MINIATURE SWINE - UNII:FY9NU6D8JD) SUS SCROFA G.(NC_010454.4)43530892C>T + 43530890_43530889insAGCTT IN OSSABAW MINIATURE SWINE 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86086-002-01 1 [arb'U] in 1 NOT APPLICABLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/03/2019 Labeler - Recombinetics, Inc. (829874523) Registrant - Recombinetics, Inc. (829874523) Establishment Name Address ID/FEI Business Operations Recombinetics, Inc. 080987344 manufacture