Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

Product Classification

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 

New Search Back To Search Results
Device antigen, galactomannan, aspergillus spp.
Regulation Description Aspergillusspp. serological reagents.
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.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNOM
Submission Type 510(k)
Regulation Number 866.3040
Device Class 1
GMP Exempt? No
Third Party Review Not Third Party Eligible
 
-
-
-
-
-