Data / Medical devices / Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (MVO): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO, Class U). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on April 19, 2004, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MVO
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Phamatech Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 1 | February 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | May 23, 2002 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | May 23, 2002 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | May 23, 2002 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 19, 2004. 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.