AccessGUDID - DEVICE: DG Reader (08437014205176)

GUDID

Device Identifier (DI) Information

Brand Name: DG Reader
Version or Model: 213779
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 213779
Company Name: DIAGNOSTIC GRIFOLS SA

Primary DI Number: 08437014205176
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 463625602 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64179	Agglutination assay digital imaging reader/analyser IVD	An electrically-powered laboratory instrument designed to be used to capture digital images of a clinical specimen from a dedicated specimen slide/cartridge/card and provide image analysis of an agglutination or haemagglutination assay. It is a benchtop instrument that includes a tray, slot or drawer, where the specimen is placed for optical image acquisition, and dedicated software for analysis, visualization and storage of the acquired images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBC	Manual Blood Grouping And Antibody Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f88f72df-bb48-4d71-a16b-0ad3772d8c39
Public Version Date: April 14, 2025
Public Version Number: 6
DI Record Publish Date: September 06, 2016