AccessGUDID - DEVICE: Schistosoma mansoni IgG ELISA (07640158219607)

GUDID

Device Identifier (DI) Information

Brand Name: Schistosoma mansoni IgG ELISA
Version or Model: 9600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9600
Company Name: Bordier affinity products S.A.

Primary DI Number: 07640158219607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 487811143 *Terms of Use

Device Description: The Schistosoma mansoni ELISA test is a qualitative enzyme immunoassay for the detection of Schistosoma mansoni and Schistosoma haematobium antibodies in human serum 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):	No
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?
52376	Multiple Schistosoma species 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 multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

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
Handling Environment Temperature: between -20 and 37 Degrees Celsius
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: 231cb7f5-26f4-49da-bdac-47ba2ede1c60
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: August 09, 2022