Microhematocrit Rotor

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K930415 ↗

FDA Product Code

GKG

Device Class

Class II

Regulation

21 CFR Part 864.6400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Microhematocrit Rotor used for?

  The Microhematocrit Rotor is designed specifically for capillary tube hematocrit analysis. It separates blood components by centrifugal force, enabling accurate measurement of the hematocrit—a critical diagnostic indicator of red blood cell volume in blood samples. This process is essential in clinical hematology for assessing conditions related to anemia, polycythemia, or dehydration.

• Is the Microhematocrit Rotor single-use or reusable?

  The Microhematocrit Rotor is supplied as a single-use item. This design ensures consistency in results and reduces the risk of cross-contamination between samples, which is particularly important in clinical settings where precision and sterility are critical.

• Which centrifuge models is the Microhematocrit Rotor compatible with?

  The rotor is compatible with a range of centrifuge models, including those from Sorvall and HemoCue. Its design adheres to standard centrifuge specifications, allowing it to function effectively in laboratory settings where hematocrit measurements are routinely performed.

• How should the Microhematocrit Rotor be stored?

  Storage of the Microhematocrit Rotor should follow the manufacturer’s guidelines to maintain its functionality. Proper storage conditions help preserve the rotor’s integrity and ensure reliable performance when used in conjunction with microhematocrit tubes and compatible centrifuges.

• Is the Microhematocrit Rotor sterile?

  No, the Microhematocrit Rotor is not sterile. It is intended for single-use in clinical settings, and proper handling procedures must be followed to avoid contamination. Sterility is not required for this device, but aseptic techniques should still be observed during use to prevent sample compromise.