FDA device listing
447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent,447620 IMMAGE Immunochemistry Systems ASO…
FDA device listing 1105350826 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent,447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent,469165 Antistreptolysin-O Reagent (ASO- 2 x 100),OSR6194 ASO |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Product codes | GTQ |
| Device names | GTQ - Antistreptolysin - Titer/Streptolysin O Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3720 |
| Review panels | Microbiology |
| Registered establishments | BECKMAN COULTER, INC., Beckman Coulter Ireland Inc |
| Establishment registrations | 2050010, 2050012, 9680746 |
| FEI numbers | 2050010, 2050012, 1000206808 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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