Duns Number:075150847
Device Description: The Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum o 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.
Catalog Number
EIA-4114
Brand Name
Anti-Thyroid Peroxidase (Anti-TPO) ELISA
Version/Model Number
EIA-4114
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K971834
Product Code
JNL
Product Code Name
IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY
Public Device Record Key
e8be4073-76d5-4529-8de7-2c7f51fb7d8d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
March 20, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |