Duns Number:312576506
Device Description: Reagent Red Blood Cells; 3.0 - 3.4%; pooled cells for use in detection of unexpected antib Reagent Red Blood Cells; 3.0 - 3.4%; pooled cells for use in detection of unexpected antibodies with TANGO instruments; 10ml
Catalog Number
816065100
Brand Name
Biotestcell® Pool
Version/Model Number
816065100
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
61c82ff6-8b6d-4b40-815e-ef964a07f00d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2014
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 |