FDA device listing
JJX TearLab Osmolarity Control
FDA device listing 1821957703 · BIONOSTICS, INC.
Key facts
| Proprietary names | JJX TearLab Osmolarity Control |
|---|---|
| Owner/operator | BIONOSTICS, INC. |
| Owner/operator number | 1220649 |
| Product codes | JJX, OND |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), OND - Osmolality Of Tears |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1540, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | BIONOSTICS, INC. |
| Establishment registrations | 1220649 |
| FEI numbers | 1220649 |
| Establishment operations | Contract 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