AccessGUDID - DEVICE: NovaLisa Strongyloides (ENTISTRO06900)

GUDID

Device Identifier (DI) Information

Brand Name: NovaLisa Strongyloides
Version or Model: STRO0690
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STRO0690
Company Name: Gold Standard Diagnostics Frankfurt GmbH

Primary DI Number: ENTISTRO06900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330328514 *Terms of Use

Device Description: The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or plasma (citrate or 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?
52405	Strongyloides stercoralis 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 the parasitic nematode Strongyloides stercoralis in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDT	Elisa, Trichinella Spiralis

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: 3e0f84a3-4091-4926-a4b3-9e7d9ce7fb3c
Public Version Date: September 10, 2024
Public Version Number: 2
DI Record Publish Date: August 27, 2024