Data / Medical devices / United States / Geneoscopy Inc
Geneoscopy Inc: FDA-registered device maker in Saint Louis, MO, United States, 1 PMA approval
Geneoscopy Inc is registered with the FDA (registration 3026996410) in Saint Louis, MO, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated May 3, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026996410
- Address
- 2220 Welsch Industrial Ct, Saint Louis, MO, United States, 63146
- Owner or operator
- Geneoscopy Inc (10085052)
- Roles
- Manufacturer
- First device listed
- May 6, 2024
- Registered through
- 2026
- Brand names listed
- ColoSense
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection | SBB | 3 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | P230001 | ColoSense® | SBB | 12 | September 8, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2025 | 97017 | Class II | Ongoing | ColoSense Test Kit, Part No. 80-001, component of ColoSense test | Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit. | accessdata.fda.gov |
Updated September 8, 2026. 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.