R. Prowazekii 12 well; 10 pk - I-RPR01X
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of the rickettsial bacteria associated with typhus in a clinical specimen, using an agglutination method. Rickettsia species intended to be detected may include Rickettsia typhi/R. mooseri, R. prowazekii and/or R. felis.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00813545026103
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