Duns Number:312576506
Device Description: Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in detection of unexpected antibodies with I Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in detection of unexpected antibodies with IH-Cards; 2 x 10 mL
Catalog Number
814050100
Brand Name
IH-Cell I-II
Version/Model Number
814050100
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
Yes
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
-
Product Code Name
-
Public Device Record Key
4395778e-e56b-4279-99a2-ffeb7a9897db
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 20, 2017
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. | 38 |
| U | Unclassified | 21 |