Duns Number:328133103
Device Description: ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBOD ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROID PEROXIDASE (TPO) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
Catalog Number
ORG503
Brand Name
ANTI-TPO
Version/Model Number
ORG503
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K952129
Product Code
JZO
Product Code Name
System, Test, Thyroid Autoantibody
Public Device Record Key
ab036091-ffbc-4487-9c9d-76de78703dff
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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. | 21 |