Panels › Clinical Chemistry › Product code CGX · Class 2
Alkaline Picrate, Colorimetry, Creatinine
Regulation 862.1225
2510(k)s in 12 months (159 all time)
1recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in CGX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2026 | Siemens Healthcare Diagnostics, Inc. Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. Open, Classified |
CGX | K132638 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933 Open, Classified |
CGX | K110530 |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Chemistry Calibrator Terminated |
CGX | K161494 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CGX | K860418 |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method Terminated |
CGX | K110137 |
| Sep 16, 2015 | Pointe Scientific, Inc. Pointe Scientific Creatinine Reagent
Catalog number C7539-150
in vitro diagnostic
C7539-150 kit includes one R1 and one R2 bottle.
R1: HDPE plastic bottle. 120 ml fill.
R2: HDPE plastic bottle. 90 Terminated |
CGX | K830556 |
| Mar 15, 2013 | Beckman Coulter Inc. Creatinine, Part Numbers OSR6178, OSR6678
Product Usage:
System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. Terminated |
CGX | K924692 K934361 |
| Nov 14, 2012 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.
The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for t Terminated |
CGX | K072115 |
| Jan 15, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Creatinine Flex(R) Reagent Cartridges.
The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vi Terminated |
CGX | K925668 |
| Dec 27, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Creatinine Flex(R) Reagent Cartridges
The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vis Terminated |
CGX | K925668 |
| Sep 9, 2010 | Beckman Coulter Inc. SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525
Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma Terminated |
CGX | K965240 |
| Mar 9, 2010 | Pointe Scientific, Inc. Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250.
For th Terminated |
CGX | K830556 |
| Mar 9, 2010 | Pointe Scientific, Inc. Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-5 Terminated |
CGX | K830556 |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322.
An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for t Terminated |
CGX | K951595 |
| Aug 17, 2004 | Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20 Terminated |
CGX | K981799 |
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