ATELLICA IM ELF KIT

ATELLICA IM ELF KIT
ATELLICA IM ELF KIT - 11208118

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with liver fibrosis in a clinical specimen, using a chemiluminescent immunoassay method. The range of analytes detected may include, but is not limited to, hyaluronic acid (HA), procollagen type III N-terminal propeptide (PIIINP), tissue inhibitor of matrix metalloproteinase 1 (TIMP-1).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QQB

Device Name: Prognostic Test For Assessment Of Liver Related Disease Progression

Device Class: 2

Physical State: The test system may include clinical analyzers, reagents, calibrators, and controls.

Definition: prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Assay to measure analyte(s) that are markers of liver disease progression.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The test system is an in vitro diagnostic device that measures human samples.

Regulation Number: 862.1622

Third Party Flag: N

Medical Specialty: CH

Device Id: 00630414618463

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