Product code NOM— Microbiology

MycoMEIA Aspergillus Assay

Classification name: Antigen, Galactomannan, Aspergillus Spp.
Device class: Class 1
Regulation: 21 CFR 866.3040
Advisory panel: Microbiology
Total cleared: 4
First cleared: 2003-05-16
Most recent: 2025-08-01

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code NOM under 21 CFR 866.3040, via openFDA

Market context for product code NOM

FDA has cleared 4 devices under product code NOM between 2003 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20251 clearance
20111 clearance
20061 clearance
20031 clearance

Top applicants under product code NOM

Bio-Rad3 clearances
Pearl Diagnostics, Inc.1 clearance

Recent clearances under product code NOM

K243496 — MycoMEIA Aspergillus AssayPearl Diagnostics, Inc.·2025-08-01
K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793Bio-Rad·2011-01-13
K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793Bio-Rad·2006-06-02
K023857 — PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794Bio-Rad·2003-05-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.