Duns Number:075150847
Device Description: The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intac The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.
Catalog Number
EIA-3645
Brand Name
PTH (Parathyroid) Intact ELISA
Version/Model Number
EIA-3645
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
K974306
Product Code
CEW
Product Code Name
RADIOIMMUNOASSAY, PARATHYROID HORMONE
Public Device Record Key
2435202b-41f2-46f7-a306-efb9f66196a4
Public Version Date
March 30, 2020
Public Version Number
3
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 |