Duns Number:061446282
Device Description: Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
Catalog Number
-
Brand Name
Panoscreen EXTEND
Version/Model Number
0002383
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QHT
Product Code Name
Reagent Red Blood Cells
Public Device Record Key
9adb0473-c4df-4934-99fb-146fffb6b937
Public Version Date
October 31, 2019
Public Version Number
1
DI Record Publish Date
October 23, 2019
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |