Duns Number:010655581
Device Description: In Vitro Diagnostics testing kit R1:3X60mL, R2:3X12mL
Catalog Number
IRN1150
Brand Name
ClearChem Diagnostics Inc. Iron
Version/Model Number
IRN1150
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
Yes
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
5cad99ca-4eef-4008-aab4-b20584c235fe
Public Version Date
May 31, 2018
Public Version Number
1
DI Record Publish Date
April 30, 2018
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |