Duns Number:061446282
Device Description: This product is used in the detection of unexpected red blood cell blood group antibodies. This product is used in the detection of unexpected red blood cell blood group antibodies. This product is a two (2) vial set, with each vial containing a 2 - 4% reagent red blood cell suspension of a unique group O donor of known antigen make-up.
Catalog Number
0002390
Brand Name
Panoscreen I and II
Version/Model Number
0002390
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
eb299c68-ce25-4f69-88a2-aa73d6f5e999
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |