The Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements of TPO autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.
Anti-Thyroid Peroxidase (Anti-TPO) ELISA - EIA-4114
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
- Serum Diluent
- Total Volume: 8 Milliliter
- Biotin Reagent
- Total Volume: 13 Milliliter
- Total Volume: 7 Milliliter
- Total Volume: 20 Milliliter
- Total Volume: 1 Milliliter
- Wash Solution
- Substrate A
- Stop Solution
- Enzyme Reagent
- Calibrators
- Substrate B
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JNL
Device Name: Immunochemical, Thyroglobulin Autoantibody
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: 866.5870
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00840239041142
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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