HE4 EIA

HE4 EIA - 404-10US

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method.

• Size Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OIU

Device Name: Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Device Class: 2

Physical State: IVD

Definition: An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: dual-site sandwich enzyme immunoassay of human serum or plasma; may be measured by stand-alone spectrophotometer or automated immunoassay analyzer

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: IVD

Regulation Number: 866.6010

Third Party Flag: Y

Medical Specialty: IM

Device Id: 17350066140326

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