FDA device listing
NATtrol™ C. difficile Negative Control,NATtrol™ C. difficile Positive Control,NATtrol™ Chlamydia trachomatis (CT)…
FDA device listing 1380623240 · Zeptometrix
Key facts
| Proprietary names | NATtrol™ C. difficile Negative Control,NATtrol™ C. difficile Positive Control,NATtrol™ Chlamydia trachomatis (CT) Positive Control,NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control,NATtrol™ CT/NG Negative Control Pack,NATtrol™ CT/NG/TV Negative Control,NATtrol™ CT/NG/TV Positive Control,NATtrol™ CT Positive Control Pack,NATtrol™ Flu/RSV/SARS-CoV-2 Negative… |
|---|---|
| Owner/operator | Zeptometrix |
| Owner/operator number | 10050261 |
| Product codes | OHQ |
| Device names | OHQ - Multi-Analyte Controls Unassayed |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | ZEPTOMETRIX LLC, ZEPTOMETRIX LLC. |
| Establishment registrations | 3000202849, 3012101172 |
| FEI numbers | 1318994, 3000202849 |
| 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