Spotted Fever Rickettsia IgG ELISA Kit

Basic Information

• Brand Name: Spotted Fever Rickettsia IgG ELISA Kit
• Primary DI: B266SFG96K0
• Version / Model: N/A
• Catalog Number: SFG96K
• Company Name: FULLER LABORATORIES
• Labeler DUNS: 859340390
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-31
• Public Version: 1
• Public Version Date: 2019-11-08
• Public Version Status: New
• Public Device Record Key: 7431c521-2bbd-4232-a856-817e9f551dd7

Device Description

An EIA assay for spotted fever Rickettsiosis IgG levels

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
51285	Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to one or multiple species of the rickettsial bacteria associated with spotted fever in a clinical specimen, using an enzyme immunoassay (EIA) method. Rickettsia species intended to be detected may include Rickettsia rickettsii, R. akari, R. conorii, R. sibirica, R. australis, R. japonica, R. africae, R. honei and/or R. felis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B266SFG96K0	HIBCC

Storage Conditions

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