ATELLICA IM ELF MCM SET

ATELLICA IM ELF MCM SET
ATELLICA IM ELF MCM SET - 11208708

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple antigens or markers associated with liver fibrosis in a clinical specimen. 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: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 00630414618111

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