AccessGUDID - DEVICE: AccuDiag ™ (00894175000336)

GUDID

Device Identifier (DI) Information

Brand Name: AccuDiag ™
Version or Model: DACD-2550-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2550-1
Company Name: Diagnostic Automation, Inc.

Primary DI Number: 00894175000336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878252071 *Terms of Use

Device Description: AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) The Diagnostic Automation Rheumatoid Factor (RF) Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection of IgM antibodies in human serum to RF antigen and as an aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use. High complexity test.

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:	Yes
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?
54845	Multiple rheumatoid arthritis-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 rheumatoid arthritis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrulline peptide.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHR	System, Test, Rheumatoid Factor

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: Storage and Handling Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 96 Tests (1 Kit)

Device Record Status

Public Device Record Key: 629d9d4b-8b36-43a5-b6fe-bc2dd6c5bad1
Public Version Date: August 16, 2021
Public Version Number: 1
DI Record Publish Date: August 06, 2021