QkVue iFOB Control Set
QuickVue - 20197
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).
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: KHE
Device Name: Reagent, Occult Blood
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.6550
Third Party Flag: Y
Medical Specialty: HE
Device Identifiers
Device Id: 30014613201977
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
