FDA device listing
Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs),LV…
FDA device listing 1842601685 · BiOptic Inc.
Key facts
| Proprietary names | Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs),LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs),Micro Vial; Sample tray; Buffer tray; Droppers; PCR tubes; 16+3-well Sample Tube; Rotor plate (for 16+3 tube) |
|---|---|
| Owner/operator | BiOptic Inc. |
| Owner/operator number | 10086887 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | BIOPTIC INC. |
| Establishment registrations | 3010030414 |
| FEI numbers | 3010030414 |
| 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