Albumin Reagent Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841063 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Sgpt Reagent Set

  Class I

  FDA 510(k) K841060 Active Cleared 1 May 1984

• Alkaline Phosphotase Reagent Set

  Class II

  FDA 510(k) K841064 Active Cleared 1 May 1984

• Creatinine Reagent Set

  Class II

  FDA 510(k) K841070 Active Cleared 1 May 1984

• Glucose Enzymatic Reagent Set

  Class II

  FDA 510(k) K841055 Active Cleared 1 May 1984

• Msi-Cal 8

  Class II

  FDA 510(k) K883851 Active Cleared 22 Nov 1988

• Msi-Hct

  Class II

  FDA 510(k) K924926 Active Cleared 7 Jan 1993

See all devices from Medical Specialties, Inc. →

• What is the Albumin Reagent Set used for?

  The Albumin Reagent Set is used for the quantitative photometric measurement of albumin in human serum and plasma, employing the Bromcresol Green Dye-Binding method to determine albumin levels in clinical laboratory settings.

• Which analyzers is the Albumin Reagent Set compatible with?

  The Albumin Reagent Set is intended for use with automated Beckman Coulter AU/DxC AU analyzers, as specified in the device description, and is supplied as a reagent set for these systems.

• Is the Albumin Reagent Set a single-use or reusable device?

  The Albumin Reagent Set is supplied as a reagent set for in vitro diagnostic use, and based on its description as a consumable reagent for automated analyzers, it is designed for single-use in clinical testing procedures.

• What storage conditions are required for the Albumin Reagent Set?

  The device requires specific storage conditions as stated in the description, though exact temperature or humidity details are not provided in the data; users should follow the manufacturer’s labeling for proper storage to maintain reagent stability.

• What regulatory pathway was used for the Albumin Reagent Set?

  The Albumin Reagent Set was cleared by the FDA through a traditional 510(k) submission, identified by k_number K841063, and is classified as a Class II device under product code CIX and regulation number 862.1035.