Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests

QTU · Not classified · Unknown

Classification

FDA Product Code: QTU
Device class: Not classified
Regulation: —
Review panel: MI
Medical specialty: Unknown
Submission type: 7
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

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