Label: EXEGEN CLN2 MINISWINE- pcln2-blast excised not applicable
- NDC Code(s): 86093-2004-1
- Packager: Exemplar Genetics LLC (dba Precigen Exemplar)
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated April 13, 2020
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ExeGen CLN2 miniswine
ExeGen CLN2 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pCLN2 which exhibit similar phenotypes to human patients with CLN2 disease. These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorization 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 homozygous and heterozygous offspring resulting from a heterozygous founder, in which the CLN2 gene has been disrupted by the homologous recombination of a single copy of a mutated CLN2-PGK construct in exon 6 for use in biomedical research. The desirable animal will be a homozygote CLN2 R208X Blast Excised/R208X 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.
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INGREDIENTS AND APPEARANCE
EXEGEN CLN2 MINISWINE
pcln2-blast excised not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86093-2004 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLN2 RDNA CONSTRUCT DISRUPTING EXON 6 OF CLN2 GENE IN YUCATAN MINIATURE SWINE (UNII: 6J81TO7Z9U) (CLN2 RDNA CONSTRUCT DISRUPTING EXON 6 OF CLN2 GENE IN YUCATAN MINIATURE SWINE - UNII:6J81TO7Z9U) CLN2 RDNA CONSTRUCT DISRUPTING EXON 6 OF CLN2 GENE IN YUCATAN MINIATURE SWINE 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86093-2004-1 1 [arb'U] in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2020 Labeler - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121) Registrant - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121) Establishment Name Address ID/FEI Business Operations Exemplar Genetics LLC (dba Precigen Exemplar) 958331121 manufacture