Duns Number:087248183
Device Description: Quantikine IVD Human SolubleTransferrin Receptor ELISA Kit
Catalog Number
DTFR1
Brand Name
Research and Diagnostic Systems
Version/Model Number
DTFR1
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
-
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
K970718
Product Code
JNM
Product Code Name
Immunochemical, Transferrin
Public Device Record Key
aa5d8291-ad2e-443e-a70d-0bc6b44c1154
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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. | 135 |