FDA device listing
BioSign Flu control set (5 Pos/5 Neg),BioSign hCG S/U Pos/Neg controls (2 x 3 mL),BioSign Mono Pos/Neg control,PBM…
FDA device listing 1706604814 · PRINCETON BIOMEDITECH CORP.
Key facts
| Proprietary names | BioSign Flu control set (5 Pos/5 Neg),BioSign hCG S/U Pos/Neg controls (2 x 3 mL),BioSign Mono Pos/Neg control,PBM Qualitative Cardiac Marker Control Set (2 x 1mL),Status COVID-19 Antigen Controls (1 pos/1 neg); Bulk,Status COVID-19/Flu control set (5 Pos/5 Neg),Status Drugs of Abuse Controls (2 x 5mL),Status Flu control set (5 Pos/5 Neg),Status hCG urine Pos/Neg controls (2 x 2.5 mL),Status H… |
|---|---|
| Owner/operator | PRINCETON BIOMEDITECH CORP. |
| Owner/operator number | 2246703 |
| Product codes | JJX |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | Princeton BioMeditech Corp., PRINCETON BIOMEDITECH CORP. |
| Establishment registrations | 2246703, 3026478115, 3026478116 |
| FEI numbers | 2246703, 3026478115, 3026478116 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database