Duns Number:317134468
Device Description: Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantib Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies against thyroid peroxidase (TPO) in human serum or plasma.
Catalog Number
EIA-3561
Brand Name
Anti TPO Ab ELISA
Version/Model Number
EIA-3561
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
ab68a351-e928-4f5c-9bcc-9466d9606d60
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
June 10, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |