Panels › Immunology › Product code DCK · Class 2
C-Reactive Protein, Antigen, Antiserum, And Control
Regulation 866.5270
0510(k)s in 12 months (126 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
Top companies in DCK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2025 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides. Open, Classified |
DCK | K152433 K953197 |
| Nov 25, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma
Model/Catalog Number: 1926740 Open, Classified |
DCK | K152433 K953197 |
| Sep 30, 2024 | Randox Laboratories CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum
Catalogue number: CP3826 Open, Classified |
DCK | K953212 |
| Jun 26, 2017 | Medtest Holdings, Inc. Pointe Scientific CRP(HS) Wide Range Control Set and
Pointe Scientific CRP(HS) Wide Range Standard Set
5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Ra Terminated |
DCK | K030545 |
| Oct 26, 2016 | Ortho-Clinical Diagnostics VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740 Terminated |
DCK | K152433 K953197 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990
VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS Terminated |
DCK | K030626 |
| Jun 27, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990,
Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measur Terminated |
DCK | None listed |
| Apr 25, 2013 | Alere San Diego, Inc. The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807.
Product Usage:
Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Ch Terminated |
DCK | K040579 |
| Mar 4, 2010 | Kamiya Biomedical Company, LLC "K-ASSAY CRP (3) Calibrator E".
This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbi Terminated |
DCK | K023828 |
| Mar 2, 2010 | Beckman Coulter Inc IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280.
Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelome Terminated |
DCK | K981638 |
| Sep 20, 2008 | Cholestech Corp Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determin Terminated |
DCK | K040579 |
| May 6, 2006 | Kamiya Biomedical Company K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The Terminated |
DCK | K992312 |
| Jan 8, 2005 | Ortho-Clinical Diagnostics Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rocheste Terminated |
DCK | K030626 |
| Sep 18, 2004 | Ortho-Clinical Diagnostics VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are f Terminated |
DCK | K030626 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DCK | K854542 |
| Jan 6, 2004 | Polymedco, Inc POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For Terminated |
DCK | K001009 |
| Jan 6, 2004 | Polymedco, Inc POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only.
COMMON/USUAL NAME: High-Sensitive C-Reactiv Terminated |
DCK | K001009 |
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