Duns Number:061446282
Device Description: Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells fr Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume.
Catalog Number
0066052
Brand Name
Specimen Diluent
Version/Model Number
0066052
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
-
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
BK070016
Product Code
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
674426a2-3468-449a-9fb7-79bcdd3b7b96
Public Version Date
October 10, 2022
Public Version Number
6
DI Record Publish Date
April 18, 2016
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 |