FDA device listing
ACE Calcium-Arsenazo Reagent (urine),ACE Creatinine Reagent (urine),ACE Inorganic Phosphorus U.V. Reagent (urine),ACE…
FDA device listing 1314553563 · Carr Biosystems, LLC
Key facts
| Proprietary names | ACE Calcium-Arsenazo Reagent (urine),ACE Creatinine Reagent (urine),ACE Inorganic Phosphorus U.V. Reagent (urine),ACE Urea Nitrogen Reagent (urine),ACE Urine Standard |
|---|---|
| Owner/operator | Carr Biosystems, LLC |
| Owner/operator number | 10028192 |
| Premarket submissions | K103615 |
| Product codes | CDN, CEO, CGX, CJY, JIX |
| Device names | CDN - Urease, Photometric, Urea Nitrogen, CEO - Phosphomolybdate (Colorimetric), Inorganic Phosphorus, CGX - Alkaline Picrate, Colorimetry, Creatinine, CJY - Azo Dye, Calcium, JIX - Calibrator, Multi-Analyte Mixture |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1145, 862.1150, 862.1225, 862.1580, 862.1770 |
| 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