Factor XII Deficient Plasma B12D

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K843451 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Chemical Co. →

• What is the Factor XII Deficient Plasma B12D used for?

  The Factor XII Deficient Plasma B12D is a diagnostic reagent designed specifically for qualitative and quantitative assays to detect hereditary or acquired deficiencies of coagulation factor XII (FXII). It serves as a reference standard with less than 1% residual FXII activity, enabling precise measurement of patient samples in coagulation studies. This helps clinicians diagnose FXII-related bleeding disorders more accurately.

• How is the Factor XII Deficient Plasma B12D supplied and prepared for use?

  The reagent is supplied in lyophilized (freeze-dried) form, intended exclusively for in vitro diagnostic use in laboratory settings. Before use, it must be reconstituted following standard laboratory protocols for coagulation reagents. The lyophilized format ensures stability during storage and transport, while the reconstitution step activates the reagent for testing patient samples.

• Is the Factor XII Deficient Plasma B12D sterile, and what storage precautions are required?

  The product does not explicitly state sterility requirements beyond typical precautions for diagnostic reagents. As a lyophilized reagent, it should be stored in a clean, dry environment protected from moisture and extreme temperatures. Standard laboratory storage conditions (e.g., refrigeration if specified by the manufacturer) should be followed to maintain integrity until use. Always refer to the manufacturer’s instructions for detailed storage guidelines.

• Can the Factor XII Deficient Plasma B12D be reused, or is it intended for single-use?

  The Factor XII Deficient Plasma B12D is designed for single-use in diagnostic assays. Once reconstituted and used for testing patient samples, it should not be reused to avoid contamination or loss of accuracy. Lyophilized reagents like this are formulated for one-time use per vial to ensure reliable and consistent results in coagulation studies.

• What regulatory pathway was followed for this device, and what class does it belong to?

  The Factor XII Deficient Plasma B12D is classified as a Class II medical device under FDA regulations (21 CFR 864.7290), indicating moderate risk and requiring premarket notification (510(k)) clearance. It received a Substantially Equivalent determination via a Traditional 510(k) pathway (K843451) in 1984, meaning it was deemed comparable to a legally marketed predicate device at the time. This classification ensures it meets FDA standards for safety and effectiveness in diagnostic use.