Data / Medical devices / Multiple Use Blood Lancet For Single Patient Use Only / United States
FDA-registered makers of Multiple Use Blood Lancet For Single Patient Use Only in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Multiple Use Blood Lancet For Single Patient Use Only (product code QRL). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Multiple Use Blood Lancet For Single Patient Use Only
- Product code
- QRL
- Country
- United States
Makers of Multiple Use Blood Lancet For Single Patient Use Only in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fondcircle Inc. | Newport Beach, CA, United States | Specification developer | 2 | November 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Trividia Health, Inc. | Fort Lauderdale, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | October 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ascensia Diabetes Care US Inc. | Parsippany, NJ, United States | Specification developer | 1 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ascensia Diabetes Care US Inc. | Valhalla, NY, United States | Specification developer | 1 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| BiometerPlus USA, Inc. | Fremont, CA, United States | Repackager or relabeler, Specification developer | 1 | August 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Facet Technologies, LLC. | Atlanta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stat Medical Devices, Inc. | North Miami Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.