Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K981931 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent

  Class II

  FDA 510(k) K981632 Active Cleared 15 Jun 1998

• Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P

  Class II

  FDA 510(k) K983892 Active Cleared 13 Apr 1999

• What clinical conditions can these folate assays help diagnose?

  The CEDIA Red Blood Cell Folate Reagent Pack, CEDIA Folate Assay, and Elecsys Folate Assay are designed to quantitatively measure folate levels in human red blood cells. These assays assist in diagnosing folate-related deficiencies such as megaloblastic anemia, where low folate levels impair red blood cell production, and monitoring folate status in pregnant women to assess risks for neural tube defects. By providing precise folate concentration data, clinicians can tailor patient management and supplementation strategies accordingly.

• How are these reagent packs and assays supplied, and do they require additional sterilization?

  The CEDIA Red Blood Cell Folate Reagent Pack, CEDIA Folate Assay, and Elecsys Folate Assay are supplied as single-use reagents in sterile packaging. No additional sterilization is required beyond what the manufacturer provides. This ensures safety and reliability for in vitro diagnostic use in clinical chemistry laboratories, minimizing contamination risks and maintaining assay integrity.

• Which immunoassay analyzers are compatible with these folate assays?

  These assays are specifically designed for use on the Elecsys 2010 immunoassay analyzer. Compatibility with other analyzers is not indicated, so clinicians must confirm the analyzer model matches the device specifications to ensure accurate and reliable folate measurement results.

• Are these assays reusable, or are they intended for single-use?

  The CEDIA Red Blood Cell Folate Reagent Pack, CEDIA Folate Assay, and Elecsys Folate Assay are explicitly labeled as single-use reagents. Reusing these reagents could compromise sterility, accuracy, and patient safety, leading to unreliable diagnostic results. Adhering to single-use guidelines ensures consistency and compliance with in vitro diagnostic best practices.

• Where can I find storage instructions and expiration dates for these assays?

  Storage conditions and expiration dates for the CEDIA Red Blood Cell Folate Reagent Pack, CEDIA Folate Assay, and Elecsys Folate Assay are clearly indicated on the packaging. Proper storage is critical to maintaining assay performance and preventing degradation. Always follow the manufacturer’s instructions to ensure the reagents remain effective until their expiration date.