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Sign in to claim this brandEntroGen, Inc.
United States·US-MF-000022721
Last updated September 18, 2026
What EntroGen, Inc. makes
EntroGen, Inc. manufactures laboratory reagents and kits for genomic DNA isolation, including pureNA® products for both cell-free and traditional DNA extraction. Their portfolio also includes bisulfite conversion reagents, next-generation sequencing (NGS) adapter and library preparation kits for Illumina® platforms, as well as quantification and fragmentation assays for DNA analysis. Additionally, they produce automated workflow solutions like the Benchbot® 4800 and molecular diagnostic assay kits, such as the CRCDx RAS Mutation Detection Assay Kit.
The company’s devices are classified under EU Medical Device Regulation (MDR) as Class A and Class III, with relevant listings in the EUDAMED database and FDA’s Premarket Approval (PMA) registry. Their products are designed for in vitro diagnostic (IVD) use and molecular biology applications, adhering to regulatory requirements for both research and clinical diagnostic settings.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 20950, Warner Center Lane, Woodland Hills, United States
- Website
- www.entrogen.com
- —
- —
- [email protected]
- Phone
- +1 818-716-1070
- PRRC Contact
- Gary Potikyan
- EUDAMED SRN
- US-MF-000022721
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| pureNA® Genomic DNA Isolation Kit | GDNA-50 | EUDAMED | Class A | Active |
| Bisulfite Conversion Kit | BCK-RT50 | EUDAMED | Class A | Active |
| Internal Quality Control Assay | IQCA-RT50 | EUDAMED | Class A | Active |
| NGS Adapter Kit for Illumina® | NGS-ADP | EUDAMED | Class A | Active |
| Library Quantification for Illumina® | LIBQ-NGS | EUDAMED | Class A | Active |
| Library Prep Purification Kit | NGS-BDS | EUDAMED | Class A | Active |
| pureNA® Cell-Free DNA Isolation Kit | CFDNA-50 | EUDAMED | Class A | Active |
| DNA Fragmentation Quantification Assay | FQA-RT40 | EUDAMED | Class A | Active |
| NGS Library Prep Kit For Illumina® | NGS-LIG | EUDAMED | Class A | Active |
| Benchbot® 4800 | BBOT4800 | EUDAMED | Class A | Active |
| CRCDx RAS Mutation Detection Assay Kit | P220005 | FDA PMA | Class III | Active |
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