iHealth

Basic Information

• Brand Name: iHealth
• Primary DI: 00850078377128
• Version / Model: ICR-3000
• Company Name: IHEALTH LAB INC.
• Labeler DUNS: 054953337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-02
• Public Version: 1
• Public Version Date: 2026-01-12
• Public Version Status: New
• Public Device Record Key: 421357de-b5e9-427f-b64b-2dbd914faad3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	866.3987	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850078377125	GS1		4	In Commercial Distribution
Primary	00850078377128	GS1
Package	20850078377122	GS1		72	In Commercial Distribution