AccessGUDID - DEVICE: Echinococcus multilocularis (Em18) IgG ELISA (07640158219317)

GUDID

Device Identifier (DI) Information

Brand Name: Echinococcus multilocularis (Em18) IgG ELISA
Version or Model: 9310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9310
Company Name: Bordier affinity products S.A.

Primary DI Number: 07640158219317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 487811143 *Terms of Use

Device Description: The Echinococcus multilocularis (Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples. This test is intended for post-operative and/or post-therapeutic follow-up of infected patients.

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?
52217	Echinococcus multilocularis 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 Echinococcus multilocularis in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Echinococcus multilocularis, a parasitic tapeworm associated with hydatid disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GPF	Antigen, Agglutinating, Echinococcus Spp.

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: e997fadb-7e6a-49e9-830e-76512d6e5d40
Public Version Date: August 25, 2022
Public Version Number: 1
DI Record Publish Date: August 17, 2022