CDN · Urease, Photometric, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | CDN |
|---|---|
| Device Name | Urease, Photometric, Urea Nitrogen |
| Regulation | 21 CFR 862.1770 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Classification Rationale
Class II.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | Mar 14, 2019 | SESE |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Hitachi Chemical Diagnostics, Inc. | Oct 28, 2013 | SESE |
| K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | Alfa Wassermann Diagnostics Technologies, LLC | May 21, 2013 | SESE |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Aug 10, 2012 | SESE |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | Alfa Wassermann Diagnostic Technologies, Inc. | Sep 8, 2011 | SESE |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | Jul 20, 2000 | SESE |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Cholestech Corp. | Jul 24, 1997 | SESE |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | May 15, 1996 | SESE |
| K943042 | BUN QVET | Prisma Systems | Dec 29, 1994 | SESE |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | King Diagnostics, Inc. | Oct 13, 1992 | SESE |
| K914903 | QUICKSTART UREA NITROGEN | Em Diagnostic Systems, Inc. | Dec 31, 1991 | SESE |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | Aug 5, 1982 | SESE |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | Nov 12, 1980 | SESE |
| K792328 | STATTEK BUN | Boehringer Mannheim Corp. | Dec 18, 1979 | SESE |
| K781253 | BUN (UREASE) REAGENT | Coulter Electronics, Inc. | Aug 21, 1978 | SESE |
| K771442 | MULTISTAT III UREA NITROGEN TEST | Instrumentation Laboratory CO | Aug 22, 1977 | SESE |
Top Applicants
- Alfa Wassermann Diagnostic Technologies, Inc. — 2 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
- Alfa Wassermann Diagnostics Technologies, LLC — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Cholestech Corp. — 1 clearance
