FDA.reportPublic FDA data

iHealth

Primary DI
00850044118465
Brand
iHealth
Company
iHealth Labs Inc.
Model
ICF-3000
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20850044118469PackageGS15In Commercial Distribution
30850044118466PackageGS136In Commercial Distribution
00850044118465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085004411846920850044118469
3085004411846630850044118466
00850044118465008500441184658500441184650850044118465

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044118441iHealthICF-30002026-07-14
00850044118670iHealthKN-550BT2026-07-14
00850044118687iHealthKD-7232026-07-14
00850078377005iHealthPO32026-07-14
00850078377234iHealthKN-550LT2026-07-14
00850078377265iHealthBG5SKIT2026-07-14
20850044118452iHealthICF-30002024-05-24
00850044118052iHealthICO-30002022-09-30
00855111003040iHealthBP52016-08-31
00856362005258iHealthTS28B2017-04-24
00850044118045iHealthICO-30002022-09-30
00850044118236iHealthBG5SKIT2024-05-28
00850044118243iHealthBG5SKIT2024-05-27
00856362005043iHealthPT32020-07-31
00856362005159iHealthBG5SKIT2025-12-19
00850044118083iHealthPT32023-08-14
00850044118007iHealthKD-7232022-09-29
00850044118205iHealthEGS-20032023-08-24
00850044118250iHealthEGS-20032023-08-30
00850044118267iHealthEGS-20032023-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044118441iHealthiHealth 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
10850042559564CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850044118427iHealthiHealth Labs Inc.QMN2024-05-25
20850044118452iHealthiHealth Labs Inc.QMN2024-05-24