Label: OSSAPIG-LD-NASH MINIATURE SWINE (pnpla3 hindiii restriction fragment length polymorphism- rflp positive for one or two copies of pnpla3-i148m not applicable
- NDC Code(s): 86086-004-01
- Packager: Recobimbinetics, Inc.
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated July 24, 2024
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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 CTC>GAA base substitution at base pairs 5,087,871-5,087,873 that generates a HindIII restriction enzyme site used to genotype progeny from gene edited founders, a C>G base substitution at base pair 5,087,864 that creates a coding sequence change from isoleucine to methionine at amino acid 148 of the swine PNPLA3 protein, and synonymous base substitutions; T>C at base pair 5,087,861 and G>C at base pair 5,087,858 and GAC>CTG at base pairs 5,087,853-5,087,855.
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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-LD-NASH 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-LD-NASH animals, or any materials derived from the OssaPig-LD-NASH animals, are not intended to enter the human or animal food supply.
OssaPig-LD-NASH 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-LD-NASH animals, and all materials derived from the OssaPig-LD-NASH 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-LD-NASH MINIATURE SWINE
pnpla3 hindiii restriction fragment length polymorphism (rflp) positive for one or two copies of pnpla3-i148m not applicableProduct Information Product Type Item Code (Source) NDC:86086-004 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA G.(NC_010447.5) 5087853-5087855GAC>CTG+5087858G>C+5087861T>C+5087864C>G+5087871-5087873CTC>GAA ALTERATION TO EXON 3 OF PNPLA3 GENE IN OSSABAW BREED MINIATURE SWINE (UNII: L6JJ1CLP4K) (SUS SCROFA G.(NC_010447.5) 5087853-5087855GAC>CTG+5087858G>C+5087861T>C+5087864C>G+5087871-5087873CTC>GAA ALTERATION TO EXON 3 OF PNPLA3 GENE IN OSSABAW BREED MINIATURE SWINE - UNII:L6JJ1CLP4K) SUS SCROFA G.(NC_010447.5) 5087853-5087855GAC>CTG+5087858G>C+5087861T>C+5087864C>G+5087871-5087873CTC>GAA ALTERATION TO EXON 3 OF PNPLA3 GENE IN OSSABAW BREED MINIATURE SWINE 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86086-004-01 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 01/06/2020 Labeler - Recobimbinetics, Inc. (829874523) Registrant - Recombinetics, Inc. (829874523) Establishment Name Address ID/FEI Business Operations Recombinetics, Inc. 080987344 manufacture