Fungal Serology

Basic Information

• Brand Name: Fungal Serology
• Primary DI: 10634853000244
• Version / Model: 200200
• Catalog Number: 200200
• Company Name: MICROBIOLOGICS INC.
• Labeler DUNS: 060467826
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-26
• Public Version: 2
• Public Version Date: 2024-02-09
• Public Version Status: Update
• Public Device Record Key: 1fc22563-01df-45be-8cdb-73fc4f193430
• Distribution End Date: 2023-11-30

Device Description

Aspergillus niger Antigen, 1mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JWT	ANTIGEN, CF, ASPERGILLUS SPP.	Microbiology	866.3040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51982	Multiple Aspergillus species antigen IVD, control	A material which is used to verify the performance of an assay 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10634853000244	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius