Histoplasma Antigen for Fungal Immunodiffusion 100201

GUDID 00840733101021

Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.

MERIDIAN BIOSCIENCE, INC.

Histoplasma capsulatum antigen IVD, reagent

• Primary Device ID: 00840733101021
• NIH Device Record Key: 133f14ef-4667-4fe6-b6fe-09f27914f883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histoplasma Antigen for Fungal Immunodiffusion
• Version Model Number: 100201
• Catalog Number: 100201
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733101021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792701

FDA Product Code

• GMJ: Antigens, Histoplasma Capsulatum, All

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

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