MESOMARK

MESOMARK - 801-905

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mucin-like carcinoma-associated antigen (MCA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

• Size Type = Tests Per Kit; Size Unit = 96; Unit of Measure = Tests

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OAW

Device Name: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

Device Class: f

Physical State: Assay kit including capturing and detecting antibody, buffers, controls and calibrators.

Definition: A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.

Submission Type ID: 6

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: In vitro diagnostic test usinh human serum.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00869164000000

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