FDA.reportPublic FDA data

iHealth

Primary DI
00850044118427
Brand
iHealth
Company
iHealth Labs Inc.
Model
ICF-3000
Published
2024-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QMNCovid-19 Multi-Analyte Antigen Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMNCovid-19 Multi-Analyte Antigen DeviceUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044118424PackageGS11In Commercial Distribution
20850044118421PackageGS11In Commercial Distribution
30850044118428PackageGS148In Commercial Distribution
00850044118427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004411842410850044118424
2085004411842120850044118421
3085004411842830850044118428
00850044118427008500441184278500441184270850044118427

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testingA 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.

Regulatory Flags#

DUNS number
054953337
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850044118462iHealthICF-30002026-07-14
10850078377187iHealthICR-30002026-05-15
20850044118056iHealthICO-30002022-09-30
20850044118421iHealthICF-30002024-05-25
20850044118438iHealthICF-30002024-05-24
20850044118445iHealthICF-30002026-07-14
50850044118040iHealthICO-30002022-09-30
50850044118064iHealthICO-30002022-09-30
50856362005895iHealthICO-30002022-09-16
50856362005901iHealthICO-30002022-09-16
20850044118452iHealthICF-30002024-05-24
00850044118861iHealthANC12024-10-30
10850078377224iHealthICR-30002026-01-30
10850078377095iHealthICR-30002026-01-02
10850078377101iHealthICR-30002026-01-02
10850078377125iHealthICR-30002026-01-02
10850078377132iHealthICR-30002026-01-02
00850044118441iHealthICF-30002026-07-14
00850044118465iHealthICF-30002026-07-14
00850044118670iHealthKN-550BT2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850044118462iHealthiHealth Labs Inc.QMN2026-07-14
20850044118445iHealthiHealth Labs Inc.QMN2026-07-14
00850044118441iHealthiHealth Labs Inc.QMN2026-07-14
00850044118465iHealthiHealth Labs Inc.QMN2026-07-14
00850044118656iHealthiHealth Labs Inc.QMN2026-05-15
00816862026863WELLlife™ WONDFO USA CO., LTD.QMN2025-05-16
10816862026860WELLlife™ WONDFO USA CO., LTD.QMN2025-05-16
00816862026153WELLlife™WONDFO USA CO., LTD.QMN2024-12-24
10816862026150WELLlife™WONDFO USA CO., LTD.QMN2024-12-24
00816862024586WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024630WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024661WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024685WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024708WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024722WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024583WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024637WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024668WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024682WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024705WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024729WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024500WELLlife™ WONDFO USA CO., LTD.QMN2024-09-24
10816862024507WELLlife™ WONDFO USA CO., LTD.QMN2024-09-24
30810107290041Flowflex Plus COVID-19 and Flu A/B Home TestACON LABORATORIES, INC.QMN2024-08-14
00850042559536CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559550CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559567CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559529CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559533CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559557CorDx TyfastCORETESTS, INC.QMN2024-06-13