Label: YORKAPIG-HF-RBM20 SWINE (rbm20 bglii restriction fragment length polymorphism- rflp positive for one or two copies of rbm20-r636s not applicable
- NDC Code(s): 86086-003-01
- Packager: Recombinetics, Inc.
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated October 27, 2020
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STATEMENT OF IDENTITY
Identity: Transcription activator-like effector nuclease (TALEN) edit and homology dependent repair in Yorkshire breed porcine fetal fibroblasts to introduce a C>A base substitution at base pair 121,244,982 that generates a BglII restriction enzyme site used to genotype progeny from gene edited founders, a CG>TC base substitution at base pairs 121,244,988-121,244,989 that creates a coding sequence change from arginine to serine at amino acid 638 of the swine RBM20 protein, and a synonymous AG>TC base substitution at base pairs 121,244,991-121,244,992.
- HEALTH CLAIM
- CONTRAINDICATIONS
- 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
WARNINGS & 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.
YorkaPig-HF-RBM20 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.
YorkaPig-HF-RBM20 animals, or any materials derived from the YorkaPig-HF-RBM20 animals, are not intended
to enter the human or animal food supply.
YorkaPig-HF-RBM20 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 YorkaPig-HF-RBM20 animals, and all materials derived from the
YorkaPig-HF-RBM20 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
YORKAPIG-HF-RBM20 SWINE
rbm20 bglii restriction fragment length polymorphism (rflp) positive for one or two copies of rbm20-r636s not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86086-003 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA G.(NC_010456.5)121244982C>A + 121244988-121244989CG>TC + 121244991-121244992AG>TC ALTERATION TO EXON 9 OF RBM20 GENE IN YORKSHIRE BREED LARGE WHITE SWINE (UNII: O4OJ2CP48E) (SUS SCROFA G.(NC_010456.5)121244982C>A + 121244988-121244989CG>TC + 121244991-121244992AG>TC ALTERATION TO EXON 9 OF RBM20 GENE IN YORKSHIRE BREED LARGE WHITE SWINE - UNII:O4OJ2CP48E) SUS SCROFA G.(NC_010456.5)121244982C>A + 121244988-121244989CG>TC + 121244991-121244992AG>TC ALTERATION TO EXON 9 OF RBM20 GENE IN YORKSHIRE BREED LARGE WHITE SWINE 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86086-003-01 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 - Recombinetics, Inc. (829874523) Registrant - Recombinetics, Inc. (829874523) Establishment Name Address ID/FEI Business Operations Recombinetics, Inc. 080987344 manufacture