Duns Number:878252071
Device Description: AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA KitA collection of reagents and other AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of soluble transferrin receptor protein in a clinical specimen, using an enzyme immunoassay (EIA) method.
Catalog Number
3126-15
Brand Name
AccuDiag™
Version/Model Number
DACD 3126-15
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DDG
Product Code Name
Transferrin, Antigen, Antiserum, Control
Public Device Record Key
fa2c0f42-6322-4158-9403-cbff7c8f043a
Public Version Date
September 15, 2021
Public Version Number
1
DI Record Publish Date
September 07, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |