CA 125 - IMMULITE - RGT - 100 Tests

CA 125
IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) - 10380969

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

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: 00630414964331

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