The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitaive determination of soluable transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems.


Product Overview

The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitaive determination of soluable transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Access sTfR - A32493


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of soluble transferrin receptor in a clinical specimen.


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: DDG

Device Name: Transferrin, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5880

Third Party Flag: Y

Medical Specialty: IM


Device Identifiers

Device Id: 15099590202811

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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