Home › Device types › NHX
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
FDA product code NHX · Class 2 · Immunology
53
Registered devices
44
Adverse events
9
Recalls
21
510(k) clearances
Devices with this code
Dilution Plate, Phadia 250 — Phadia ABEliA CCP Well — Phadia ABEliA IgG Calibrator Strip — Phadia ABEliA IgG Calibrators — Phadia ABQUANTA Lite® CCP3.1 IgG/IgA ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.IMMULITE® 2000 Systems CCP Anti-CCP IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDEliA CCP Positive Control 2500/5000 — Phadia ABARCHITECT — Abbott GmbHIMMUNOSCAN CCPlus — Svar Life Science ABEliA IgG Curve Control — Phadia ABAxis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA — AXIS-SHIELD DIAGNOSTICS LIMITEDEliA Dummy Well — Phadia ABBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.EDIA anti-CCP — Svar Life Science ABQUANTA Flash® CCP3 Reagents — INOVA DIAGNOSTICS, INC.EliA Sample Diluent — Phadia ABAnti-CCP ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGPhadia 2500E — Phadia ABARCHITECT — Abbott GmbHEliA IgG Calibrator Well — Phadia ABAtellica IM aCCP — Siemens Healthcare Diagnostics Inc.Phadia 2500EE — Phadia ABPhadia 5000E — Phadia AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2023-02-21 | Bio-Rad Laboratories, Inc. | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while per |
| 2023-02-21 | Bio-Rad Laboratories, Inc. | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while per |
| 2019-08-14 | Siemens Healthcare Diagnostics, Inc | Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be com |
| 2019-07-16 | Roche Diagnostics Operations, Inc. | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 mo |
| 2019-07-16 | Roche Diagnostics Operations, Inc. | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 mo |
| 2017-01-30 | Phadia US Inc | Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigatio |
| 2016-02-14 | Euro Diagnostica AB | Decreasing performance overtime. |
| 2005-11-11 | Axis-Shield Diagnostics, Ltd. | The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sod |
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