AccessGUDID - DEVICE: WADiana Compact (08437014205183)

GUDID

Device Identifier (DI) Information

Brand Name: WADiana Compact
Version or Model: 213789
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 213789
Company Name: DIAGNOSTIC GRIFOLS SA

Primary DI Number: 08437014205183
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 463625602 *Terms of Use

Device Description: WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana Compact analyzer automates test processing functions and 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?
56714	Blood group/antibody screening analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform pre-transfusion blood group testing, red cell antibody screening/identification and/or red cell phenotyping of clinical specimens or donor specimens in order to determine suitability for transfusion or transplantation. Testing may include ABO, Rhesus or other red cell blood group systems and may use microplate-based serological methods, cassettes or column agglutinating technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

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: d70b72e8-10ad-4e02-ab86-76ecd031341c
Public Version Date: April 16, 2025
Public Version Number: 5
DI Record Publish Date: September 06, 2016