AccessGUDID - DEVICE: Cornybacterium diphtheriae toxin IgG ELISA (00840239038241)

GUDID

Device Identifier (DI) Information

Brand Name: Cornybacterium diphtheriae toxin IgG ELISA
Version or Model: EIA-3824
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3824
Company Name: DRG International Inc

Primary DI Number: 00840239038241
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The Corynebacterium diphtheriae toxin IgG ELISA is intended for the quantitative determination of IgG class antibodies against Corynebacterium diphtheriae toxin in human serum or plasma (citrate, heparin).

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?
50883	Corynebacterium diphtheriae immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Corynebacterium diphtheriae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GOS	Antiserum, Fluorescent, C. Diphtheriae

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: 2e8691ab-ebe3-40fb-a946-afb07fc562e4
Public Version Date: September 04, 2023
Public Version Number: 1
DI Record Publish Date: August 25, 2023