R. Conorii 12 well; 10 pk

Basic Information

• Brand Name: R. Conorii 12 well; 10 pk
• Primary DI: 00813545026080
• Version / Model: I-RCI01X
• Catalog Number: I-RCI01X
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5e7f3888-3b85-4100-a363-34b81e2b6b98

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
51420	Rickettsia conorii antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Rickettsia conorii in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Rickettsia conorii, the rickettsial bacteria from the Spotted Fever Group.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545026080	GS1

Customer Contacts

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