Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010791816

FEI Number

3010791816

Entity Name

ENTROGEN, INC

City/State/Country

Woodland Hills, CA, US

Establishment Address

20950 Warner Center Lane, Suite B, Woodland Hills, CA 91367, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EntroGen, Inc (Owner Number: 10088140)

Owner / Operator Contact Address

20950 Warner Center Lane, Suite B, Woodland Hills, CA 91367, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P220005

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2023-05-31
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2023-09-30

Official Correspondent

Gary Potikyan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EntroGen, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010791816. Last updated year: 2026. Please use registration number 3010791816 when referencing this establishment in official correspondence.