The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilute patient samples containing CEA concentrations greater than the Access CEA Calibrator S5

The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilute patient samples containing CEA concentrations greater than the Access CEA Calibrator S5
Access CEA Diluent - 33206

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) in a clinical specimen, using a chemiluminescent immunoassay method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DHX

Device Name: System, Test, Carcinoembryonic Antigen

Device Class: 2

Physical State: N/A

Definition: N/A

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: 15099590624828

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