Protopath Factor VIII Assay

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K834051 ↗

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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• What is the PROTOPATH FACTOR VIII ASSAY used for?

  The PROTOPATH FACTOR VIII ASSAY is a test used to measure Factor VIII levels in blood samples, helping to identify qualitative and quantitative factor deficiencies. It is specifically designed for laboratory use.

• How is the PROTOPATH FACTOR VIII ASSAY supplied?

  The PROTOPATH FACTOR VIII ASSAY is supplied as a test kit. It contains all necessary components for laboratory professionals to measure Factor VIII levels in blood samples according to established protocols.

• What is the regulatory classification of the PROTOPATH FACTOR VIII ASSAY?

  The PROTOPATH FACTOR VIII ASSAY is classified as Class II with special controls. It received FDA 510(k) clearance on February 4, 1984, with the K number K834051, indicating it meets safety and effectiveness requirements.

• Is the PROTOPATH FACTOR VIII ASSAY single-use or reusable?

  The device information does not specify whether the PROTOPATH FACTOR VIII ASSAY is single-use or reusable. As a laboratory test kit, it may contain components that are used for multiple tests or require specific handling procedures.