Quinidine Reagent Test Kit LBZ

No FDA recalls on record, checked 6 Oct 2026.

Full name

Quinidine Reagent Test Kit

510(k) Number

K830963 ↗

FDA Product Code

LBZ

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Beckman Instruments, Inc. →

• What is the Quinidine Reagent Test Kit LBZ used for?

  The Quinidine Reagent Test Kit LBZ is designed for the qualitative detection of quinidine in biological samples, such as blood or urine. It helps laboratory professionals identify the presence of quinidine, a medication used to treat abnormal heart rhythms, particularly in cases where monitoring for toxicity or overdose is required. This test supports clinical toxicology workflows by providing rapid, reliable results to guide patient care.

• How is the Quinidine Reagent Test Kit LBZ supplied and intended for use?

  The kit is supplied as a single-use diagnostic reagent intended exclusively for in vitro use in clinical laboratories. It is not designed for reusable applications or use in MRI environments. Each kit is pre-packaged for one-time testing, ensuring sterility and consistency in results. Laboratories must follow standard practices for handling and storage to maintain accuracy and compliance.

• Is the Quinidine Reagent Test Kit LBZ sterile and reusable?

  The Quinidine Reagent Test Kit LBZ is supplied in a sterile, single-use format, meaning each kit is intended for one test cycle only. Sterility is critical for preventing contamination and ensuring reliable results in clinical toxicology testing. Reuse is not authorized, as it could compromise the integrity of the enzyme immunoassay and introduce cross-contamination risks.

• What regulatory clearance does the Quinidine Reagent Test Kit LBZ hold?

  The Quinidine Reagent Test Kit LBZ holds FDA 510(k) clearance under the product code LBZ, with the clearance number K830963. This classification confirms it meets regulatory standards for enzyme immunoassays and clinical toxicology diagnostics as a Class II device under FDA regulations (862.3320). The kit adheres to established guidelines for diagnostic accuracy and safety in laboratory settings.

• How should the Quinidine Reagent Test Kit LBZ be stored?

  The kit should be stored according to manufacturer guidelines, typically in a cool, dry place protected from direct sunlight and extreme temperatures. Proper storage conditions are essential to preserve the stability and performance of the enzyme immunoassay reagents. Laboratories should refer to the included instructions for specific storage recommendations, ensuring the kit remains effective until use.