Duns Number:463625602
Device Description: The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro im The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel® 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), the Erytra® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.
Catalog Number
210400
Brand Name
Erytra
Version/Model Number
210400
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
-
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
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
dcba80b9-059e-4602-8eb0-b37b9cb6c955
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
May 20, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |