COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)

Basic Information

• Brand Name: COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)
• Primary DI: B379RCFPCK201
• Version / Model: RCFP-CK20
• Company Name: INBIOS INTERNATIONAL, INC
• Labeler DUNS: 004006628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-06
• Public Version: 1
• Public Version Date: 2025-10-14
• Public Version Status: New
• Public Device Record Key: 6be0133e-da45-42bb-ad98-81c62460a786

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
48247	Multiple-genus respiratory virus antigen 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 antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B379RCFPCK201	HIBCC