Alpha-1-Antitrypsin Kit, Qualitative Phenotype

OBZ · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5130

Classification

FDA Product Code: OBZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5130
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

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