AccessGUDID - DEVICE: FREND COVID-19 total Ab (08809317540924)

GUDID

Device Identifier (DI) Information

Brand Name: FREND COVID-19 total Ab
Version or Model: FREND COVID-19 total Ab
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FRCOA 020
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317540924
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687910463 *Terms of Use

Device Description: The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.

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:	No
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?
64827	SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a fluorescent immunoassay 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
QKO	Reagent, Coronavirus Serological

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c7391c5c-935a-44cf-a430-61bb3653edaa
Public Version Date: July 23, 2024
Public Version Number: 3
DI Record Publish Date: September 02, 2020