Cytokeratin Fragments 21-1 Eia Kit

OVK · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010

Classification

FDA Product Code: OVK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6010
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 7

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown