FDA device listing
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
FDA device listing 1775969049 · CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Key facts
| Proprietary names | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader |
|---|---|
| Owner/operator | CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
| Owner/operator number | 2431980 |
| Premarket submissions | K200506 |
| Product codes | JJQ, QCH, QFO |
| Device names | JJQ - Colorimeter, Photometer, Spectrophotometer For Clinical Use, QCH - Assayed Quality Control Material For Clinical Microbiology Assays, QFO - Zika Virus Serological Reagents |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.2300, 866.3920, 866.3935 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Chembio Diagnostic Systems, CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
| Establishment registrations | 2431980, 3026565854 |
| FEI numbers | 2431980, 3026565854 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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