Platelia Aspergillus IgG
Platelia - 62786
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the fungus Aspergillus fumigatus in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- 48 tests
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KFG
Device Name: Antiserum, Positive Control, Aspergillus Spp.
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: N
Medical Specialty: MI
Device IdentifiersDevice Id: 03610520002490
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