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Urease And Glutamic Dehydrogenase, Urea Nitrogen
FDA product code CDQ · Class 2 · Clinical Chemistry
108
Registered devices
345
Adverse events
6
Recalls
117
510(k) clearances
Devices with this code
UREA — RANDOX LABORATORIES LIMITEDPointe BUN Reagent — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCAU — Beckman Coulter, Inc.UREA-L3K — SEKISUI DIAGNOSTICS, LLCBUN/BS480 — Medtest Dx, Inc.UREA — RANDOX LABORATORIES LIMITEDTeco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSUREA — RANDOX LABORATORIES LIMITEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPOINTE SCIENTIFIC BUN Liquid — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® BUN REAGENT PRODUCT NO. DT252 — CAROLINA LIQUID CHEMISTRIES CORPORATIONUREA — RANDOX LABORATORIES LIMITEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDUrea/Bun — Roche Diagnostics GmbHKinetic UV assay for ureaurea nitrogen — Roche Diagnostics GmbHAU — Beckman Coulter, Inc.Alinity — Abbott GmbHUrea Nitrogen Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Kinetic UV assay for ureaurea nitrogen — Roche Diagnostics GmbHADVIA® Chemistry UN Urea Nitrogen Reagents — Siemens Healthcare Diagnostics Inc.BUN/BS200 — Medtest Dx, Inc.JAS Diagnostics — DREW SCIENTIFIC, INC.Dimension® Flex® reagent cartridge BUN — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-08 | Siemens Healthcare Diagnostics, Inc. | There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, t |
| 2023-06-13 | Randox Laboratories Ltd. | Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea |
| 2018-03-27 | Siemens Healthcare Diagnostics, Inc. | Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. |
| 2016-02-16 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may ex |
| 2011-10-03 | Abbott Laboratories, Inc | The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus |
| 2003-11-24 | Abbott Laboratories Diagnostic Div | False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN. |
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