Label: EXEGEN SCN5A MINISWINE- pscn5a-neo not applicable
- NDC Code(s): 86093-1902-1
- Packager: Exemplar Genetics Llc
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated August 15, 2019
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ExeGen SCN5A miniswine
ExeGen SCN5A miniswine are geneticaly engineered yucatan miniature swine containing the rDNA construct pSCN5A-Neo which exibit similar phenotypes to human patients with sudden arrhythmia death syndromes (SADS). These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorizaiton and the carcasses and all materials generated from these animals will be destroyed by incineration.
Product Definition: A specific line of Yucatan miniature pigs (Sus scrofa domesticus), including heterozygous offspring resulting from a heterozygous founder in which the SCN5A gene has been disrupted by the homologous recombinaiton of a single copy of a pSCN5A-Neo construct in exon 11, for use in biomedical research.
Warning: This product is from a genetically engineered animal and may contain an investigational new animal drug. It is for research purposes only and not for use in humans or as food/feed unless authorization has been granted by the US Food and Drug Administration. In case of emergency or release contact Exemplar Genetics at 712-722-2767 or 712-441-3408.
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INGREDIENTS AND APPEARANCE
EXEGEN SCN5A MINISWINE
pscn5a-neo not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86093-1902 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HETERZYGOUS YUCATAN MINIATURE PIG SCN5A MUTATED GENE DISRUPTED BY A SCN5A-NEO RDNA CONSTRUCT IN EXON 11 (UNII: 08X2W5664O) (pSCN5A-Neo - UNII:08X2W5664O) HETERZYGOUS YUCATAN MINIATURE PIG SCN5A MUTATED GENE DISRUPTED BY A SCN5A-NEO RDNA CONSTRUCT IN EXON 11 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86093-1902-1 1 [arb'U] in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2019 Labeler - Exemplar Genetics Llc (958331121) Registrant - Exemplar Genetics LLC (958331121) Establishment Name Address ID/FEI Business Operations Exemplar Genetics LLC 958331121 manufacture