Duns Number:045623154
Device Description: Direct TIBC Reagent is for use in the determination of total iron-binding capacity in seru Direct TIBC Reagent is for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. 1 x 60ml, 1 x 20ml
Catalog Number
HI717-80
Brand Name
Pointe Scientific, Inc. Direct TIBC
Version/Model Number
HI717-80
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
bf5a456c-4132-4c8c-bbb0-048dc672362c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |