Duns Number:312576506
Device Description: Blood Grouping Reagent; Erytype S ABO Confirm; Microplate for ABO donor unit confirmation Blood Grouping Reagent; Erytype S ABO Confirm; Microplate for ABO donor unit confirmation with TANGO instruments; contains Anti-A (A003) and Anti-B (B005); 10 Plates
Catalog Number
806130100
Brand Name
Erytype S ABO Confirm
Version/Model Number
806130100
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
-
Product Code Name
-
Public Device Record Key
11984af1-5c35-4135-85ec-47763455ae2c
Public Version Date
October 19, 2021
Public Version Number
3
DI Record Publish Date
April 07, 2017
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 |