FRANCISELLA TULARENSIS ANTISERUM

Basic Information

• Brand Name: FRANCISELLA TULARENSIS ANTISERUM
• Primary DI: 00695684017026
• Version / Model: 1702
• Company Name: GERMAINE LABORATORIES, INC
• Labeler DUNS: 176458115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-21
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 96b64fa1-f479-419f-960d-528c59ac4095

Device Description

Francisella Tularensis Antiserum is intended for use as a postive control for Francisella Tularensis Antigens.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
GSK	Antiserum, Francisella Tularensis	Microbiology	866.3280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50965	Francisella tularensis total antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Francisella tularensis in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Francisella tularensis, the bacteria associated with tularaemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00695684017026	GS1