Duns Number:045623154
Device Description: Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml R2. For u Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only.
Catalog Number
14-I7517-384
Brand Name
Pointe Direct TIBC Reagent
Version/Model Number
14-I7517-384
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
23dc37cd-8006-4508-87aa-207410989571
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |