Duns Number:784143778
Device Description: The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determination of Inta The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.
Catalog Number
21-IPTHU-E01
Brand Name
PTH (Intact, 1-84) ELISA
Version/Model Number
21-IPTHU-E01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K974306
Product Code
CEW
Product Code Name
Radioimmunoassay, Parathyroid Hormone
Public Device Record Key
bd67b47c-a3e1-4140-a7cf-b172ed6f7a46
Public Version Date
December 23, 2019
Public Version Number
4
DI Record Publish Date
August 03, 2017
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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |