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Complement C4, Antigen, Antiserum, Control
FDA product code DBI · Class 2 · Immunology
27
Registered devices
1
Adverse events
2
Recalls
34
510(k) clearances
Devices with this code
Optilite C4 Kit — THE BINDING SITE GROUP LIMITEDSynchron — Beckman Coulter, Inc.C4 — RANDOX LABORATORIES LIMITEDTinaquant Complement C4 ver2 — Roche Diagnostics GmbHARCHITECT — Abbott GmbHCAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635 — CAROLINA LIQUID CHEMISTRIES CORPORATIONK-ASSAY® Complement C4 Reagent — KAMIYA BIOMEDICAL COMPANY, LLCAU — Beckman Coulter, Inc.N Antiserum to Human C4 — Siemens Healthcare Diagnostics Products GmbHHuman C4 Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDAlinity — Abbott GmbHTinaquant Complement C4 ver2 — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESPoly Rb A-Hu C4c Complement/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTDTinaquant C4 — Roche Diagnostics GmbHDimension Vista® C4 Complement Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHAlinity — ABBOTT IRELANDARCHITECT — ABBOTT IRELANDIMMAGE — Beckman Coulter, Inc.Antiserum to Human C-4 (b1e) — KENT LABORATORIES INCVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Dimension® Flex® reagent cartridge C4 — Siemens Healthcare Diagnostics Inc.N Antiserum to Human C4 — Siemens Healthcare Diagnostics Products GmbHTina-quant Complement C4 Ver.2 — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-27 | Roche Diagnostics Operations, Inc. | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was ob |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the variou |
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