FDA device listing
BioPlex 2200 APLS IgG and IgA kit
FDA device listing 1007447534 · Bio-Rad Laboratories, Inc.
Key facts
| Proprietary names | BioPlex 2200 APLS IgG and IgA kit |
|---|---|
| Owner/operator | Bio-Rad Laboratories, Inc. |
| Owner/operator number | 9929003 |
| Premarket submissions | K103834 |
| Product codes | JIX, JJX, MID, MSV |
| Device names | JIX - Calibrator, Multi-Analyte Mixture, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), MID - System, Test, Anticardiolipin Immunological, MSV - System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.5660 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Bio-Rad Laboratories, Inc. |
| Establishment registrations | 2915274 |
| FEI numbers | 2915274 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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