AccessGUDID - DEVICE: ENA Screen ELISA (00840239035714)

GUDID

Device Identifier (DI) Information

Brand Name: ENA Screen ELISA
Version or Model: EIA-3571
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3571
Company Name: DRG International Inc

Primary DI Number: 00840239035714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma samples.

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):	Yes
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?
54828	Multiple extractable nuclear antigen (ENA) 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 extractable nuclear antigens (ENA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLL	Extractable Antinuclear Antibody, Antigen And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955134	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f6a7d05-4994-46a1-b33f-1d8879ce98da
Public Version Date: September 01, 2023
Public Version Number: 1
DI Record Publish Date: August 24, 2023