AccessGUDID - DEVICE: Bio-Self COVID-19 Antigen Home Test (00197644204359)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-Self COVID-19 Antigen Home Test
Version or Model: BTK-H2205
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTEKE USA, LLC

Primary DI Number: 00197644204359
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111149202 *Terms of Use

Device Description: COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)

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):	No
Over the Counter (OTC):	Yes
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?
65454	SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	Active	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: 0a9e0909-a79a-413e-af09-53f0e9babfbc
Public Version Date: January 23, 2025
Public Version Number: 1
DI Record Publish Date: January 15, 2025