Duns Number:048144997
Device Description: For the quantitative determination of iron in serum. For in vitro diagnostic use only.
Catalog Number
501-412
Brand Name
Iron Reagent Set
Version/Model Number
R1 x 500mL, R2 x 15mL
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
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
3836e05d-fb2e-4aba-9a99-420b89bdf5ef
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 12, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |