AccessGUDID - DEVICE: Anti-dsDNA IgM ELISA (04048474035643)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-dsDNA IgM ELISA
Version or Model: EIA-3564
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-3564
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474035643
Issuing Agency: GS1
Commercial Distribution End Date: July 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodies against double-stranded DNA (dsDNA) in human serum or plasma.

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?
54902	Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRM	ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL

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
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: 09d725a4-59bf-4036-83a9-a3a12d0fe0c5
Public Version Date: July 14, 2025
Public Version Number: 4
DI Record Publish Date: June 10, 2019