The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems.

The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19
Access GI Monitor - 387687

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 19-9 (CA19-9) in a clinical specimen, using an enzyme immunoassay (EIA) method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NIG

Device Name: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Device Class: 2

Physical State: N/A

Definition: An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods.

Submission Type ID: 1

Review Panel: IM

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: 866.6010

Third Party Flag: Y

Medical Specialty: IM

Device Id: 15099590231842

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