Duns Number:315028860
Catalog Number
08252858190
Brand Name
Tina-quant Soluble Transferrin Receptor
Version/Model Number
08252858190
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
K003064
Product Code
DDG
Product Code Name
TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
cdc5fce2-f54e-4eb0-bc4b-de2be75fe8e1
Public Version Date
November 06, 2020
Public Version Number
1
DI Record Publish Date
October 29, 2020
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 | 289 |
2 | A medical device with a moderate to high risk that requires special controls. | 760 |
3 | A medical device with high risk that requires premarket approval | 63 |
U | Unclassified | 4 |