Duns Number:227530649
Device Description: A TIBC test system is a device intended for the quantitative in vitro determination of tot A TIBC test system is a device intended for the quantitative in vitro determination of total iron-binding capacity (TIBC) concentration in serum.
Catalog Number
TI8065
Brand Name
TOTAL IRON-BINDING CAPACITY 2 (TIBC_2)
Version/Model Number
TI8065
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JMO
Product Code Name
Ferrozine (Colorimetric) Iron Binding Capacity
Public Device Record Key
aa0c2c08-8374-4179-ba0c-67d6a7955986
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |