Panels › Immunology › Product code NHX · Class 2
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Regulation 866.5775
0510(k)s in 12 months (21 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in NHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. Open, Classified |
NHX | K083868 |
| Apr 12, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD Open, Classified |
NHX | K093954 K112810 |
| Apr 12, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD Open, Classified |
NHX | K093954 K112810 |
| Aug 23, 2019 | Roche Diagnostics Operations, Inc. Roche Elecsys Anti-CCP Immunoassay
Catalog # 05031656160 Terminated |
NHX | K081338 |
| Aug 23, 2019 | Roche Diagnostics Operations, Inc. Roche Elecsys Anti-CCP Immunoassay
Catalog # 07251670190 Terminated |
NHX | K081338 |
| Aug 14, 2019 | Siemens Healthcare Diagnostics, Inc Atellica IM anti-CCP IgG (aCCP) Assay
Siemens Material Number: 10732998 (100 Test)
Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the se Terminated |
NHX | K153551 |
| Aug 23, 2018 | Euro Diagnostica AB Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. Terminated |
NHX | K091657 |
| Feb 24, 2017 | Phadia US Inc EliA Sample Diluent, Article number, 83-1023-01 Terminated |
NHX | K061165 |
| Oct 3, 2006 | Axis-Shield Diagnostics, Ltd. Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) Terminated |
NHX | K021516 K023285 |
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