AccessGUDID - DEVICE: AccuDiag ™ (00894175000428)

GUDID

Device Identifier (DI) Information

Brand Name: AccuDiag ™
Version or Model: DACD-1021-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1021-2
Company Name: Diagnostic Automation, Inc.

Primary DI Number: 00894175000428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878252071 *Terms of Use

Device Description: AccuDiag ™ Gliadin IgG Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) AccuDiag ™ Gliadin IgG ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
54812	Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using an enzyme immunoassay (EIA) method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MST	Antibodies, Gliadin

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
Special Storage Condition, Specify: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type Text Device Size Text, specify: 96 Tests

Device Record Status

Public Device Record Key: 783920ca-59ca-474f-aab8-731fb4c55210
Public Version Date: August 16, 2021
Public Version Number: 1
DI Record Publish Date: August 06, 2021