Duns Number:940425333
Device Description: The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for sc The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroid peroxidase (microsome) in serum and is used as an aid in the diagnosis of thyroid disorders.
Catalog Number
3020
Brand Name
ImmunoWELL TPO IgG Quantitative Test
Version/Model Number
800-3020
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K905486
Product Code
JNL
Product Code Name
Immunochemical, Thyroglobulin Autoantibody
Public Device Record Key
3c46e55c-e4c1-4a00-8fdd-45a643bb24d5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |