Anti-Histoplasma Control Serum (Goat) for Immunodiffusion

Basic Information

• Brand Name: Anti-Histoplasma Control Serum (Goat) for Immunodiffusion
• Primary DI: 00840733101052
• Version / Model: 100601
• Catalog Number: 100601
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a924d9b9-b2e1-4473-9669-70f6bf98e94e

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
GMK	Antiserum, Positive Control, Histoplasma Capsulatum	Microbiology	866.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52087	Histoplasma capsulatum 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 antigens from the fungus Histoplasma capsulatum in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733101052	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K792679	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius