FDA device listing
Chemiluminescence Immunoassay Analyzer
FDA device listing 1082298957 · Shenzhen Increcare Biotech Co., Ltd
Key facts
| Proprietary names | Chemiluminescence Immunoassay Analyzer |
|---|---|
| Owner/operator | Shenzhen Increcare Biotech Co., Ltd |
| Owner/operator number | 10089384 |
| Product codes | JJE |
| Device names | JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | SHENZHEN INCRECARE BIOTECH CO., LTD |
| Establishment registrations | 3030493719 |
| FEI numbers | 3030493719 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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