LISS Reagent (K790498)

No FDA recalls on record, checked 22 Oct 2026.

Full name

Liss Reagent

510(k) Number

K790498 ↗

FDA Product Code

KSG

Device Class

Class II

Regulation

21 CFR Part 864.9600

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Total Bilirubin

  Class II

  FDA 510(k) K840111 Active Cleared 19 Mar 1984

• Calibrating Solution for Abl-1 & 2

  Class II

  FDA 510(k) K831018 Active Cleared 16 Jun 1983

• Reagent for Coulter Counter Model 5+11

  Class I

  FDA 510(k) K821683 Active Cleared 24 Jun 1982

• Total Protein Reagent Cs-724

  Class II

  FDA 510(k) K833950 Active Cleared 13 Jan 1984

• Cleaning Solution For Radiometer OSM2

  Class II

  FDA 510(k) K812623 Active Cleared 2 Nov 1981

• Diagnostics Po 2 Electrolyte

  Class II

  FDA 510(k) K831013 Active Cleared 8 Jun 1983

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• What is the LISS Reagent used for in a clinical setting and why is it important for blood testing?

  The LISS Reagent is specifically designed to enhance erythrocyte agglutination in hematological testing, making it easier to detect blood group antigens and irregular antibodies. By lowering ionic strength, it improves the sensitivity of blood typing and antibody screening assays, which is critical for ensuring accurate transfusion compatibility. This helps clinicians identify potential transfusion reactions or mismatches more reliably.

• Is the LISS Reagent intended for single-use or repeated use in a laboratory?

  The LISS Reagent is explicitly labeled as a sterile, single-use diagnostic media. It is packaged under controlled conditions to maintain sterility and stability, ensuring it remains safe and effective for one-time use per vial. Reuse is not recommended or supported by the manufacturer.

• How is the LISS Reagent supplied, and what should I consider when storing it?

  The LISS Reagent is supplied as a sterile, ready-to-use solution in packaging designed for laboratory diagnostics. While exact lot sizes or packaging formats aren’t detailed in the records, it is intended for in vitro use only. Storage should follow standard laboratory protocols for diagnostic media—typically at room temperature, protected from light and contamination, and within the manufacturer’s expiration date. Always check the label for specific storage instructions.

• What regulatory pathway does the LISS Reagent follow, and what does this mean for its use?

  The LISS Reagent was cleared through the FDA’s 510(k) process (K790498) under 21 CFR 864.9600, classified as a Media, Potentiating for In Vitro Diagnostic Use. This means it was deemed substantially equivalent to predicate devices already on the market, ensuring it meets FDA standards for safety and performance in hematology diagnostics. Clinicians can rely on its regulatory clearance for use in blood typing and antibody detection assays.