AccessGUDID - DEVICE: COVID-19 total Ab Control LQ (08809317540917)

GUDID

Device Identifier (DI) Information

Brand Name: COVID-19 total Ab Control LQ
Version or Model: FIC-COALQ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FIC-COALQ
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317540917
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 Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.

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?
64868	SARS-CoV-2 total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.	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: 5d6bc5c0-6896-42db-bbfd-103a3ab95a07
Public Version Date: July 23, 2024
Public Version Number: 3
DI Record Publish Date: September 02, 2020