Cell-Chex

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K780140 ↗

FDA Product Code

JPK

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Para 12 Plus

  Class II

  FDA 510(k) K901875 Active Cleared 30 May 1990

• Para 12 Plus Retics

  Class II

  CE/IVDR FDA 510(k) K000945 Active Cleared 18 Apr 2000

• Retic Chex Linearity

  Class II

  FDA 510(k) K000115 Active Cleared 27 Mar 2000

• Platelet-Chex-Human

  Class II

  FDA 510(k) K770020 Active Cleared 16 Feb 1977

• Cal-Chex Cd Plus

  Class II

  FDA 510(k) K020469 Active Cleared 4 Apr 2002

• Chem-Chex Stat

  Class I

  FDA 510(k) K961195 Active Cleared 15 May 1996

See all devices from Streck Laboratories, Inc. →

• What is the Cell-Chex Cell Body Fluid Control used for?

  The Cell-Chex Cell Body Fluid Control is designed for hematology laboratories to evaluate cell morphology in cerebrospinal and body fluid specimens. It provides standardized reference levels for red blood cells (RBCs) and white blood cells (WBCs), helping ensure accurate performance assessment across clinically relevant diagnostic ranges. This aids in maintaining consistency and reliability in laboratory testing.

• How is the Cell-Chex supplied, and what sizes are available?

  The Cell-Chex is supplied as a liquid control in two formats: a single 2 mL vial or a set of four 2 mL vials. This allows laboratories to choose the quantity that best fits their workflow and testing volume. The liquid form ensures ease of use and precise dosing for quality control purposes.

• Is the Cell-Chex single-use or reusable?

  The Cell-Chex Cell Body Fluid Control is intended for single-use only. This design minimizes the risk of contamination and ensures consistent, reliable results for each test. Single-use controls are standard in hematology quality assurance to maintain accuracy and prevent cross-contamination between tests.

• What storage conditions are required for the Cell-Chex?

  The Cell-Chex does not require special storage conditions beyond standard refrigeration. This makes it convenient for laboratories to maintain without additional infrastructure. Always store the product in its original packaging and follow the manufacturer’s guidelines to preserve its integrity until use.

• Are there different levels of Cell-Chex available, and what do they represent?

  Yes, the Cell-Chex is available in multiple levels, such as Level 1-UC and Level 2. These levels represent different standardized concentrations of cells (RBCs and WBCs) to simulate clinically relevant scenarios. Using multiple levels allows laboratories to assess instrument performance across a broader range of diagnostic values, improving overall quality control.