Duns Number:045623154
Device Description: Iron Reagent is for the quantitative determination of iron (ferrozine) in serum on Hitachi Iron Reagent is for the quantitative determination of iron (ferrozine) in serum on Hitachi analyzers. For in vitro diagnostic use only.6 x 66ml, 6 x 17ml
Catalog Number
HI904-498
Brand Name
Pointe Scientific Inc. Iron
Version/Model Number
HI904-498
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
-
Product Code
JIY
Product Code Name
Photometric Method, Iron (Non-Heme)
Public Device Record Key
d9ae8b1b-7d8b-41ae-94ce-3e167c34aef7
Public Version Date
March 29, 2018
Public Version Number
2
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 |