FDA device listing
ACE Control (LN 06U8210),ACE Control (LN 06U8610),Alere NT-proBNP for Alinity i Controls (LN 04S7911),Alinity c Ammonia…
FDA device listing 1563580263 · ABBOTT LABORATORIES
Key facts
| Proprietary names | ACE Control (LN 06U8210),ACE Control (LN 06U8610),Alere NT-proBNP for Alinity i Controls (LN 04S7911),Alinity c Ammonia Controls (LN 08P2210),Alinity c ASO Control II (LN 04S0913),Alinity c ASO Control I (LN 04S0912),Alinity c Cannabinoids Control 1 Kit (LN 09P5410),Alinity c Cannabinoids Control 2 Kit (LN 09P5411),Alinity c Hemoglobin A1c Controls (LN 08P4310),Alinity c Lp(a) Control Kit (LN… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | JJX |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT DIABETES CARE INC., ABBOTT GmbH, ABBOTT IRELAND, ABBOTT IRELAND DIAGNOSTICS DIVISION, ABBOTT LABORATORIES |
| Establishment registrations | 1415939, 2954323, 3002809144, 3005094123, 3005333358, 3008344661, 3016438761 |
| FEI numbers | 1415939, 3002803444, 3002809144, 3005094123, 3005333358, 3008344661, 3016438761 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, 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