ClearanceBrief
Panels › Clinical Chemistry › Product code CDQ · Class 2

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Regulation 862.1770

0510(k)s in 12 months (117 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
Get daily alerts for CDQSample briefCSV

Top companies in CDQ

Company510(k)sRecalls
Em Diagnostic Systems, Inc.90
Diagnostic Chemicals , Ltd.60
Abbott Laboratories41
Sigma Diagnostics, Inc.50
Boehringer Mannheim Corp.40
Emd Chemicals, Inc.40
American Research Products Co.30
Data Medical Associates, Inc.30
Olympus Corp.30
Siemens Healthcare Diagnostics, Inc.03
DateFirm and productCodeLinked 510(k)
Sep 30, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Open, Classified		 CDQNone listed
Aug 9, 2023Randox Laboratories Ltd.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Open, Classified		 CDQK923506
Mar 27, 2018Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Terminated		 CDQK991576
Feb 16, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism
Terminated		 CDQK051087
Nov 16, 2011Abbott Laboratories, Inc
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
Terminated		 CDQK981918
Dec 18, 2003Abbott Laboratories Diagnostic Div
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
Terminated		 CDQNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.