AccessGUDID - DEVICE: COVID/Flu A&B RespiraDXTM Rapid Self-Test (B379RCFS41)

GUDID

Device Identifier (DI) Information

Brand Name: COVID/Flu A&B RespiraDXTM Rapid Self-Test
Version or Model: RCFS-4
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RCFS-4
Company Name: INBIOS INTERNATIONAL, INC

Primary DI Number: B379RCFS41
Issuing Agency: HIBCC
Commercial Distribution End Date: October 06, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 004006628 *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":	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?
66040	Multiple-genus respiratory virus 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 multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. 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
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test

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: 1e526453-d625-481a-a519-05cf52e80b23
Public Version Date: May 27, 2026
Public Version Number: 3
DI Record Publish Date: October 06, 2025