AccessGUDID - DEVICE: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit (B350GSD0110290)

GUDID

Device Identifier (DI) Information

Brand Name: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
Version or Model: GSD01-1029
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GSD01-1029
Company Name: Gold Standard Diagnostics Corporation

Primary DI Number: B350GSD0110290
Issuing Agency: HIBCC
Commercial Distribution End Date: December 11, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 790524891 *Terms of Use

Device Description: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).

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?
64830	SARS-CoV-2 immunoglobulin A (IgA) 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 A (IgA) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 7e09f02b-42a7-49f4-85f2-980cb45e1464
Public Version Date: June 04, 2021
Public Version Number: 3
DI Record Publish Date: May 20, 2020