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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Somatic Gene Mutation Detection System | OWD | Class 3 | Unknown | No | 2023-05-31 |
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