Reagents, 2019-Novel Coronavirus Nucleic Acid

QJR · Not classified · Unknown

Classification

FDA Product Code: QJR
Device class: Not classified
Regulation: —
Review panel: MI
Medical specialty: Unknown
Submission type: 8
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 59

Source

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