Data / Medical devices / Bilirubin (Total And Unbound) In The Neonate Test System / United States
FDA-registered makers of Bilirubin (Total And Unbound) In The Neonate Test System in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Bilirubin (Total And Unbound) In The Neonate Test System (product code MQM). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Bilirubin (Total And Unbound) In The Neonate Test System
- Product code
- MQM
- Country
- United States
Makers of Bilirubin (Total And Unbound) In The Neonate Test System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 2 | August 15, 2011 | 0 | 1 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Telford, PA, United States | Repackager or relabeler, Specification developer | 1 | November 13, 2014 | 0 | 1 | 1 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 1 | March 19, 2001 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Specification developer | 1 | March 19, 2001 | 0 | 0 | 0 | api.fda.gov |
| Reichert Inc. | Depew, NY, United States | Manufacturer | 1 | August 18, 1992 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 1 | March 19, 2001 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.