AccessGUDID - DEVICE: NovaLisa Echinococcus IgG (ENTIECHG01300)

GUDID

Device Identifier (DI) Information

Brand Name: NovaLisa Echinococcus IgG
Version or Model: ECHG0130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ECHG0130
Company Name: Gold Standard Diagnostics Frankfurt GmbH

Primary DI Number: ENTIECHG01300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330328514 *Terms of Use

Device Description: The Echinococcus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Echinococcus 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:	No
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?
52219	Echinococcus granulosus/E. 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 granulosus and/or Echinococcus multilocularis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with the parasitic tapeworms 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
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: a094431a-74e1-4048-bb63-6e166211d912
Public Version Date: September 10, 2024
Public Version Number: 2
DI Record Publish Date: August 26, 2024