The Access Ferritin Calibrators are intended to calibrate the Access Ferritin assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Access Ferritin Calibrators - 33025
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of ferritin in a clinical specimen, using an enzyme immunoassay (EIA) 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: JMG
Device Name: Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 866.5340
Third Party Flag: Y
Medical Specialty: IM
Device Identifiers
Device Id: 15099590575045
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