Duns Number:070371210
Device Description: For use in the determination of total iron-binding capacity in serum on the Mindray BS-480 For use in the determination of total iron-binding capacity in serum on the Mindray BS-480 analyzer. For in vitro diagnostic use only.4 x 60ml, 4 x 36ml
Catalog Number
TIBC480
Brand Name
Direct TIBC Reagent
Version/Model Number
TIBC480
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
K000781
Product Code
JMO
Product Code Name
Ferrozine (Colorimetric) Iron Binding Capacity
Public Device Record Key
75b15c4a-051c-45e5-9f02-0f293d3a4516
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |