Unifast Activated Partial Thromboplastin Time Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K882325 ↗

FDA Product Code

GFO

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sclavo, Inc. →

• What is the primary clinical use of the Unifast test?

  The Unifast Activated Partial Thromboplastin Time Test is an in vitro diagnostic device intended for clinical laboratory use to measure the activated partial thromboplastin time, which is a standard hematology assessment.

• How is this device classified for regulatory purposes?

  This device is regulated as a Class 2 medical device under regulation number 864.7925. It received FDA 510(k) clearance on August 25, 1988, under submission number K882325, confirming it is substantially equivalent to predicate devices.

• Which medical specialty does this test fall under?

  The Unifast test is categorized under the hematology medical specialty, as indicated by its product code GFO and its review by the Hematology advisory committee.