Universal Reagent Factor VIII Deficient Plasma

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K970593 ↗

FDA Product Code

GJT

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Universal Reagent Factor Xii (Twelve) Deficient Plasma

  Class II

  FDA 510(k) K973143 Active Cleared 25 Sep 1997

• Factor Deficient Plasmas - Factor Xi (11)

  Class II

  FDA 510(k) K972286 Active Cleared 14 Jul 1997

• Factor Deficient Plasmas - Factor Ix (9)

  Class II

  FDA 510(k) K972288 Active Cleared 14 Jul 1997

• Universal Reagent Factor X Deficient Plasma

  Class II

  FDA 510(k) K964459 Active Cleared 18 Dec 1996

• Universal Reagent Factor Vii Deficient Plasma

  Class II

  FDA 510(k) K970607 Active Cleared 25 Apr 1997

• Factor Deficient Plasma

  Class II

  FDA 510(k) K961929 Active Cleared 10 Oct 1996

See all devices from Universal Reagents, Inc. →

• What is the primary clinical use of this Factor VIII Deficient Plasma reagent in a lab setting?

  This reagent is specifically designed for quantitative determination of Factor VIII levels in patients suspected of having congenital or acquired Factor VIII deficiency. It is used in clotting assays within hematology laboratories to measure how much Factor VIII is present in a patient’s plasma, helping to diagnose or monitor bleeding disorders related to low Factor VIII activity.

• How is the Universal Reagent Factor VIII Deficient Plasma supplied, and what type of environment is it intended for?

  The reagent is supplied as a liquid formulation, intended exclusively for in vitro diagnostic use in laboratory settings, particularly within hematology departments. Since it is not labeled as sterile or single-use/reusable, it should be handled according to standard laboratory practices for plasma-based reagents, ensuring proper contamination control and storage conditions.

• Is this device approved for use in specific medical specialties, and how does that affect its application?

  Yes, this device is classified under the Hematology medical specialty, as indicated by its FDA submission and product code (GJT). This means it is primarily intended for use in clinical settings where blood clotting disorders—such as hemophilia—are evaluated, ensuring its relevance for diagnostic assays in hematology labs rather than general or non-hematologic testing.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its current status?

  The device received FDA clearance through a Traditional 510(k) pathway (K970593) with a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device at the time of review. This clearance confirms it is legally marketed in the U.S. for its intended in vitro diagnostic use, though no ongoing regulatory updates or new indications are implied beyond its original submission.

• Are there any size or model variations for this Factor VIII Deficient Plasma, or is it supplied uniformly?

  The provided data does not specify any distinct size or model variations for this reagent. It is described as a single liquid formulation supplied for laboratory use, implying uniformity in its presentation. For exact lot sizes or packaging details, reference the manufacturer’s current labeling or technical documentation, as these may not be reflected in the regulatory submission.