The Access Thyroglobulin Calibrators are intended to calibrate the Access Thyroglobulin assay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
Access Thyroglobulin Calibrators - 33865
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroglobulin 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: MSW
Device Name: System, Test, Thyroglobulin
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: 866.6010
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 15099590227166
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