FDA device listing
ANA Conjugate,BION IFA,Diluent,IgG Conjugate,IgG Removal Reagent,IgM Conjugate
FDA device listing 1968245242 · PHADIA AB
Key facts
| Proprietary names | ANA Conjugate,BION IFA,Diluent,IgG Conjugate,IgG Removal Reagent,IgM Conjugate |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | PHADIA US INC. |
| Establishment registrations | 3004973408 |
| FEI numbers | 3004973408 |
| Establishment operations | Complaint File Establishment |
| 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