The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems.

The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems.
Access CEA Calibrators - 33205

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: 15099590624835

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