Platelia Aspergillus Ag

Platelia Aspergillus Ag
Platelia - 12014064

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of galactomannan antigens from multiple species of the fungus Aspergillus, which may include Aspergillus niger, Aspergillus flavus, Aspergillus terreus and/or Aspergillus fumigatus, in a clinical specimen, using an enzyme immunoassay (EIA) method.

• 96 tests

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NOM

Device Name: Antigen, Galactomannan, Aspergillus Spp.

Device Class: 1

Physical State: N/A

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.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3040

Third Party Flag: Y

Medical Specialty: MI

Device Id: 03610522189380

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A