AccessGUDID - DEVICE: Taenia Solium IgG ELISA (00840239035134)

GUDID

Device Identifier (DI) Information

Brand Name: Taenia Solium IgG ELISA
Version or Model: EIA-3513
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3513
Company Name: DRG International Inc

Primary DI Number: 00840239035134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: For the qualitative screening of serum or plasma IgG antibodies to Taenia solium using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique.NLD

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?
52413	Taenia solium 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 Taenia solium in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Taenia solium, the parasitic tapeworm associated with cysticercosis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDJ	REAGENTS, CYSTICERCOSIS

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: 62de5d4f-f515-4705-90bd-31477d6baff6
Public Version Date: June 15, 2021
Public Version Number: 1
DI Record Publish Date: June 07, 2021