The Access hFSH Calibrators are intended to calibrate the Access hFSH assay for the quantitative determination of follicle stimulating hormone (FSH) levels in human serum and plasma using the Access Immunoassay Systems.


Product Overview

The Access hFSH Calibrators are intended to calibrate the Access hFSH assay for the quantitative determination of follicle stimulating hormone (FSH) levels in human serum and plasma using the Access Immunoassay Systems.
Access hFSH Calibrators - 33525


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) 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: CGJ

Device Name: Radioimmunoassay, Follicle-Stimulating Hormone

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: 862.1300

Third Party Flag: N

Medical Specialty: CH


Device Identifiers

Device Id: 15099590575250

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


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