FDA Registration Active 🇺🇸 United States

THSP-ILNGS NGS Targeted Hotspot Panel

Reg #: 3010791816 · FEI: 3010791816 · Expires 2025
Products
1
Proprietary Names
45
Establishment Types
1
Classifications
1

Registration Details

Registration Name
ENTROGEN, INC
Registration Number
3010791816
FEI Number
3010791816
Status
Active
Expiry Year
2025
Initial Importer
No
Address
20950 Warner Center Lane, Suite B
City
Woodland Hills
State
CA
ZIP
91367
Country
US

Owner / Operator

Firm Name
EntroGen, Inc
Operator Number
10088140
Address
20950 Warner Center Lane, Suite B
City
Woodland Hills
State
CA
Postal Code
91367
Country
US
Correspondent
Gary Potikyan

Products

Device Name Product Code
Somatic Gene Mutation Detection System OWD

Proprietary Names

THSP-ILNGS NGS Targeted Hotspot Panel PI3K-RT48 PIK3CA Mutation Analysis Kit GDNA-50 pureNA® Genomic DNA Isolation Kit NRAS-RT50 NRAS Mutation Analysis Kit THRNA-RT32 Thyroid Cancer Fusion Gene Detection Kit LEUK3-QRT24 MLL-AF4 One-Step Detection Kit BRAFX-RT64 BRAF Codon 600 Mutation Analysis Kit II IDH-RT38 IDH1/2 Mutation Detection Kit BCR190-QRT46 BCR-ABL P190 (mbcr) One-Step Detection Kit UGT-RT50 UGT1A1 Genotyping Kit NGS-ADP NGS Adapter Kit for Illumina KRBR-RT50 KRAS/BRAF Mutation Analysis Kit EGFRX-RT52 EGFRX Mutation Analysis Kit EGFRV3-RT42 EGFRvIII Detection Kit LEUK6-QRT24 CBFb-MYH11 One-Step Detection Kit LUNG-RT48 Lung Cancer RNA Panel LEUKMP-RT24 Leukemia Translocation Panel V2 BRCAX-NGS BRCA Complete™ Expanded Panel LIBQ-NGS Library Quantification Kit for Illumina CTRAS-RT40 ctDNA RAS Mutation Detection Kit FQA-RT40 DNA Fragmentation Quantification Assay THDNA-RT64 Thyroid Cancer Mutation Detection Kit RAS-RT50 RAS Mutation Analysis Kit LEUK1-QRT24 AML1-ETO One-Step Detection Kit KRAS-RT50 KRAS Mutation Analysis Kit CTEGFR-48 ctDNA EGFR Mutation Detection Kit BCR210-AQSTD BCR-ABL P210 Quantitative Control Standards BCR210-QRT46 BCR-ABL P210 (Mbcr) One-Step Detection Kit NGS-LIG NGS Library Prep Kit For Illumina LEUK4-QRT24 PML-RARA bcr1, bcr2, bcr3 One-Step Detection Kit IQCA-RT50 Internal Quality Control Assay CRC-RT48 Colorectal Cancer Mutation Detection Panel CKIT-RT44 c-Kit Mutation Detection Kit RASX-RT50 RAS c.59/117 Mutation Detection Kit CTBRAF-48 ctDNA BRAF V600 Mutation Detection Kit MLH1-RT24 MLH1 Methylation Detection Kit LEUK5-QRT24 TEL-AML1 One-Step Detection Kit MGMT-RT44 MGMT Methylation Detection Kit BCK-RT50 Bisulfite Conversion Kit NGS-BDS Library Prep Purification Kit EGFR-RT52 EGFR Mutation Analysis Kit CFDNA-50 pureNA® Cell-Free DNA Isolation Kit LEUK2-QRT24 E2A-PBX1 One-Step Detection Kit BRCA-NGS BRCA Complete™ GIST-RT44 GIST Mutation Detection Kit

Establishment Types

Manufacture Device in the United States for Export Only