Fecal extraction device

Fecal extraction device
LIAISON Q.S.E.T. Device Plus - 319060

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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