AccessGUDID - DEVICE: Adenovirus Antigen (stool) ELISA (04048474034448)

GUDID

Device Identifier (DI) Information

Brand Name: Adenovirus Antigen (stool) ELISA
Version or Model: EIA-3444
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-3444
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474034448
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: The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative determination of adenovirus antigen in feces.

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?
49853	Adenovirus antigen 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 antigens from Adenovirus in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNY	Antisera, Fluorescent, Adenovirus 1-33

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 255272b0-178a-49cd-ae6a-f02708d65109
Public Version Date: July 14, 2025
Public Version Number: 2
DI Record Publish Date: August 29, 2023