The Access OV Monitor Calibrators are intended to calibrate the Access OV Monitor assay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems.

The Access OV Monitor Calibrators are intended to calibrate the Access OV Monitor assay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Access OV Monitor Calibrators - 386358

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, 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: LTK

Device Name: Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

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: 15099590232375

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