AccessGUDID - DEVICE: Genabio COVID-19 Rapid Self-Test Kit (00196852928675)

GUDID

Device Identifier (DI) Information

Brand Name: Genabio COVID-19 Rapid Self-Test Kit
Version or Model: RA9-E00305
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Genabio Diagnostics Inc.

Primary DI Number: 00196852928675
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 118586095 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
64829	SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, within a short period, relative to standard laboratory testing procedures, using a fluorescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses to aid the diagnosis of coronavirus disease (COVID-19) infection. It is not intended to be used for self-testing.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
QKP	Coronavirus Antigen Detection Test System.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d18d5c19-5dee-4698-ab95-f8436e6c4bf1
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 07, 2022