Data / Medical devices / United States / Entrogen, Inc
Entrogen, Inc: FDA-registered device maker in Woodland Hills, CA, United States, 1 PMA approval
Entrogen, Inc is registered with the FDA (registration 3010791816) in Woodland Hills, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated September 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010791816
- Address
- 20950 Warner Center Lane Suite B, Woodland Hills, CA, United States, 91367
- Owner or operator
- EntroGen, Inc (10088140)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- May 31, 2023
- Registered through
- 2026
- Brand names listed
- BCK-RT50 Bisulfite Conversion Kit, BCR190-QRT46 BCR-ABL P190 (mbcr) One-Step Detection Kit, BCR210-AQSTD BCR-ABL P210 Quantitative Control Standards, BCR210-QRT46 BCR-ABL P210 (Mbcr) One-Step Detection Kit, BRAFX-RT64 BRAF Codon 600 Mutation Analysis Kit II, BRCA-NGS BRCA Complete, BRCAX-NGS BRCA Complete Expanded Panel, BenchBot 4800 Liquid Handling System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Specification developer | accessdata.fda.gov |
| Somatic Gene Mutation Detection System | OWD | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 29, 2023 | P220005 | CRCDx RAS Mutation Detection Assay Kit | OWD | 0 | September 29, 2023 | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.