The Access Unconjugated Estriol Calibrators are intended to calibrate the Access Unconjugated Estriol assay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

The Access Unconjugated Estriol Calibrators are intended to calibrate the Access Unconjugated Estriol assay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
Access Unconjugated Estriol Calibrators - 33575

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

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: 862.1150

Third Party Flag: N

Medical Specialty: CH

Device Id: 15099590231149

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