The Access Progesterone II Sample Diluent is intended for use with the Access Progesterone II assay to dilute samples containing progesterone concentrations greater than the S5 calibrator on the automated Access 2 Immunoassay System and DxI 9000 Access Immunoassay Analyzer.
Access Progesterone II Sample Diluent - C81798
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 15099590752705
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