Mmp-9 Test System

PFQ · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1540

Classification

FDA Product Code: PFQ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.1540
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 6

Source

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