EXEGEN NF1 MINISWINE- pnf1-blast excised not applicable 
Exemplar Genetics, Llc

----------

pNF1-Blast Excised in miniswine

ExeGen NF1 miniswine

ExeGen NF1 miniswine are geneticaly engineered yucatan miniature swine containing the rDNA construct pNF1-Blast which exibit similar phenotypes to human patients with Neurofibromatosis. 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 NF1 gene has been disrupted by the homologous recombination of a single copy of a mutated NF1-PGK construct resulting in the deletion of exon 42 for use in biomedical research. The final sellable animal will be a heterozygous NF1 +/Ex42del Blast excised miniswine.

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 NF1 MINISWINE 
pnf1-blast excised not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-1903
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HETEROZYGOUS YUCATAN MINIATURE NF1 MUTATED GENE DISRUPTED BY A NF1-BLAST RDNA CONSTRUCT RESULTING IN THE DELETION OF EXON 42 (UNII: JJB5COM59I) (pNF1-Blast Excised - UNII:JJB5COM59I) HETEROZYGOUS YUCATAN MINIATURE NF1 MUTATED GENE DISRUPTED BY A NF1-BLAST RDNA CONSTRUCT RESULTING IN THE DELETION OF EXON 421 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-1903-21 [arb'U] in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/14/2020
Labeler - Exemplar Genetics, Llc (958331121)
Registrant - Exemplar Genetics, Llc (958331121)
Establishment
NameAddressID/FEIBusiness Operations
Exemplar Genetics, Llc958331121manufacture

Revised: 8/2019
Document Id: ee21003e-2c8d-4211-9d37-25e6f5efc7ae
Set id: 277df44e-490c-48d0-8947-1d02ef99dd01
Version: 1
Effective Time: 20190815
 
Exemplar Genetics, Llc