FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
FLU/RSV Positive Control - 751110
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GQG
Device Name: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
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: 866.3480
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840733101977
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