Qualitrol CRP Control Set

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

510(k) Number

K961829 ↗

FDA Product Code

DCK

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Qualitrol Dhp Immunoassay Control Levels 1, 2 and 3, Conformancee Mcc-Ligand Control Levels 1, 2 and 3

  Class I

  FDA 510(k) K972080 Active Cleared 18 Jun 1997

• Qualitrol, (Alfa Fetoprotein) Afp Control Set

  Class I

  FDA 510(k) K961912 Active Cleared 15 Aug 1996

• Qualitrol Rf Controls

  Class II

  FDA 510(k) K961545 Active Cleared 24 Sep 1996

• Qualitrol Syphsero Control Set

  Class II

  FDA 510(k) K961998 Active Cleared 8 Aug 1996

• Urine Chemistry Control, Level 2

  Class I

  FDA 510(k) K992578 Active Cleared 3 Sep 1999

• Qualitrol Igame Controls, Levels 1 and 2

  Class I

  FDA 510(k) K961544 Active Cleared 24 Sep 1996

See all devices from Consolidated Technologies, Inc. →

• What is the Qualitrol CRP Control Set used for?

  The Qualitrol CRP Control Set is designed for use in in vitro diagnostic (IVD) laboratories to measure C-Reactive Protein (CRP) levels in serum and other body fluids. CRP is a biomarker used to assess tissue injury, inflammation, and responses to infections or autoimmune disorders. By providing standardized controls, this set helps ensure the accuracy and reliability of CRP immunoassay results.

• How is the Qualitrol CRP Control Set supplied, and is it single-use?

  The Qualitrol CRP Control Set is supplied as a single-use reagent kit. This means each package is intended for one-time use only, ensuring consistency and preventing cross-contamination between tests. The non-sterile packaging is designed to prevent contamination during storage and handling, but it is not sterile.

• Is the Qualitrol CRP Control Set sterile?

  No, the Qualitrol CRP Control Set is not sterile. It is packaged to minimize contamination risk during storage and handling, but it is not intended for sterile procedures. Users should follow the provided instructions for proper handling and storage to maintain the integrity of the controls.

• What storage conditions are required for the Qualitrol CRP Control Set?

  The Qualitrol CRP Control Set requires proper storage as outlined in the accompanying instructions. While specific storage conditions (e.g., temperature, humidity) are not detailed here, it is generally recommended to store controls in a cool, dry place away from direct sunlight and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage guidelines to ensure optimal performance.

• Is the Qualitrol CRP Control Set MRI-compatible?

  No, the Qualitrol CRP Control Set is explicitly labeled as non-MRI compatible. This means it should not be used or stored in environments where it could be exposed to MRI machines, as the device may interfere with or be damaged by magnetic fields.