The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum and plasma (lithium heparin) using the automated Access 2 Immunoassay System and DxI 9000 Access Immunoassay Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum and plasma (lithium heparin) using the automated Access 2 Immunoassay System and DxI 9000 Access Immunoassay Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Access Progesterone II - C78020

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone 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: JLS

Device Name: Radioimmunoassay, Progesterone

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1620

Third Party Flag: N

Medical Specialty: CH

Device Id: 15099590752682

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