Fungal Serology

Basic Information

• Brand Name: Fungal Serology
• Primary DI: 10634853000299
• Version / Model: 200225-1
• Catalog Number: 200225-1
• 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: 8270d3c1-6fbc-4a4d-8989-22d3f88944d5
• Distribution End Date: 2023-11-30

Device Description

Asp. Immunodiffusion Agar Plates, 1 - 7 Well Pattern

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
JZP	PLATES, OUCHTERLONY AGAR	Immunology	866.4600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64947	Agar medium preparation kit IVD	A collection of devices intended to be used for the preparation of an agar medium for subsequent culture of a clinical specimen or other diagnostic testing (e.g., minimum susceptibility testing). It typically includes agarose, a specific culture media formulation and transfer devices (e.g., vial adaptor, syringe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10634853000299	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 8 Degrees Celsius