FDA device listing
ACE Cholesterol Reagent (Axcel, plasma),ACE HDL-C Reagent (Axcel, plasma),ACE LDL-C Reagent (Axcel, plasma),ACE…
FDA device listing 1319082072 · Carr Biosystems, LLC
Key facts
| Proprietary names | ACE Cholesterol Reagent (Axcel, plasma),ACE HDL-C Reagent (Axcel, plasma),ACE LDL-C Reagent (Axcel, plasma),ACE Triglycerides Reagent (Axcel, plasma) |
|---|---|
| Owner/operator | Carr Biosystems, LLC |
| Owner/operator number | 10028192 |
| Premarket submissions | K122757 |
| Product codes | CDT, CHH, LBS, MRR |
| Device names | CDT - Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, CHH - Enzymatic Esterase--Oxidase, Cholesterol, LBS - Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, MRR - System, Test, Low Density, Lipoprotein |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1175, 862.1475, 862.1705 |
| Review panels | Clinical Chemistry |
| Registered establishments | ALFA WASSERMANN |
| Establishment registrations | 2247288 |
| FEI numbers | 1000122044 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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