Duns Number:463625602
Device Description: The DG Reader is a device designed to read, interpret, and generate reports of the results The DG Reader is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards. The instruments also identifies DG Gel 8 cards by Reading their barcodes. As a stand-alone instrument or interfaced to the customer's Laboratory Information System (LIS), the DG Reader automates data management requirements using DG Gel 8 cards and digital image processing.
Catalog Number
213779
Brand Name
DG Reader
Version/Model Number
213779
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
PBC
Product Code Name
Manual Blood Grouping And Antibody Test Systems
Public Device Record Key
f88f72df-bb48-4d71-a16b-0ad3772d8c39
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
September 06, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |