R. Rickettsii 12 well; 10 pk

R. Rickettsii 12 well; 10 pk - I-RRS01X

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Rickettsia rickettsii in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Rickettsia rickettsii, the rickettsial bacteria associated with Rocky Mountain spotted fever.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LSQ

Device Name: Reagent, Rickettsia Serological

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3500

Third Party Flag: N

Medical Specialty: MI

Device Id: 00813545026110

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A