Antigen, Galactomannan, Aspergillus Spp.

NOM · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3040

Classification

FDA Product Code: NOM
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.3040
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 3

Source

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