EXEGEN SCN5A MINISWINE- pscn5a-neo not applicable 
Exemplar Genetics Llc

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pSCN5A-Neo in miniswine

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.

warning label

EXEGEN SCN5A MINISWINE 
pscn5a-neo not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-1902
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 111 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-1902-11 [arb'U] in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2019
Labeler - Exemplar Genetics Llc (958331121)
Registrant - Exemplar Genetics LLC (958331121)
Establishment
NameAddressID/FEIBusiness Operations
Exemplar Genetics LLC958331121manufacture

Revised: 8/2019
Document Id: 2b3acec6-5eeb-443a-84b2-f415a19d2f1a
Set id: f6ef025c-5dbe-4256-a37c-8a4f34f3324f
Version: 1
Effective Time: 20190815
 
Exemplar Genetics Llc