Fecal extraction device
LIAISON Q.S.E.T. Device Plus - 319060
Device Description
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen.
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: NXO
Device Name: Calprotectin, Fecal
Device Class: 2
Physical State: n/a
Definition: The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
Submission Type ID: 1
Review Panel: IM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Enzyme-linked immunosorbent assay (ELISA)
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: n/a
Regulation Number: 866.5180
Third Party Flag: Y
Medical Specialty: IM
Device Identifiers
Device Id: 08056771602884
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
