The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Antibody assay for the quantitative determination of thryoperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems.
Access TPO Antibody Calibrators - A18227
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using an enzyme immunoassay (EIA) method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.
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: 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 IdentifiersDevice Id: 15099590202019
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