FDA device listing
Autoplex® 2nd Generation ELISA & CLIA Analyzer (IN006-2),Autoplex® 3rd Generation ELISA & CLIA Analyzer…
FDA device listing 1726025842 · MONOBIND, INC.
Key facts
| Proprietary names | Autoplex® 2nd Generation ELISA & CLIA Analyzer (IN006-2),Autoplex® 3rd Generation ELISA & CLIA Analyzer (IN006-3),Autoplex® ELISA Analyzer & CLIA Processor (IN006),Immunoassay Plate Washer (IN002),Impulse3® CLIA Analyzer (IN007),LuMatic® CLIA Analyzer (IN008),NeoEldex® ELISA Analyzer (IN009),NeoLumax® CLIA Analyzer (IN010),PrisMatic® ELISA Analyzer (IN013),TITIN® ELISA Analyzer (IN016-E),TITIN®… |
|---|---|
| Owner/operator | MONOBIND, INC. |
| Owner/operator number | 2020726 |
| Product codes | JJQ |
| Device names | JJQ - Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2300 |
| Review panels | Clinical Chemistry |
| Registered establishments | MONOBIND, INC. |
| Establishment registrations | 2020726 |
| FEI numbers | 2020726 |
| Establishment operations | Specification Developer |
| 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