Ehrlichia chaffeensis 12wl; 10 pk

Basic Information

• Brand Name: Ehrlichia chaffeensis 12wl; 10 pk
• Primary DI: 00813545025649
• Version / Model: I-ECH01X
• Catalog Number: I-ECH01X
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: 6e8e32a4-7b6e-4e95-a171-37484c51018b

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
LSQ	Reagent, Rickettsia Serological	Microbiology	866.3500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51397	Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM 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 immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Ehrlichia chaffeensis in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Ehrlichia chaffeensis, the rickettsial bacteria associated with human monocytic ehrlichiosis (HME).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545025649	GS1

Customer Contacts

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