FDA.reportPublic FDA data

iHealth

Primary DI
00850078377180
Brand
iHealth
Company
iHealth Labs Inc.
Model
ICR-3000
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
SCAMulti-Analyte Respiratory Virus Antigen Detection Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCAMulti-Analyte Respiratory Virus Antigen Detection TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251085000iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.2025-12-12SCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850078377187PackageGS125In Commercial Distribution
20850078377184PackageGS112In Commercial Distribution
00850078377180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007837718710850078377187
2085007837718420850078377184
00850078377180008500783771808500783771800850078377180

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856362005814iHealthPT12021-04-01
00850044118656iHealthICF-3000P2026-05-15
00850078377272iHealthCSW-ANSCR2026-05-15
00850044118427iHealthICF-30002024-05-25
00850044118434iHealthICF-30002024-05-24
00850044118458iHealthICF-30002024-05-24
00856362005890iHealthICO-30002022-09-16
00856362005906iHealthICO-30002022-09-16
00850044118205iHealthEGS-20032023-08-24
00850044118236iHealthBG5SKIT2024-05-28
00850044118250iHealthEGS-20032023-08-30
00850044118267iHealthEGS-20032023-08-30
00856362005005iHealthKN-550BT2022-10-01
00856362005050iHealthBPM12023-08-14
00856362005104iHealthBP3L2022-09-30
00856362005142iHealthBP5S2025-03-03
00856362005159iHealthBG5SKIT2025-12-19
00856362005197iHealthEGS-20032019-01-09
00856362005821iHealthPT3SBT2021-04-14
00850044118922iHealthKN-550LT2025-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078377272iHealthiHealth Labs Inc.SCA2026-05-15
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00311917077598WalgreensWALGREEN CO.SCA2026-04-28
00050428373927CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDSCA2026-04-27
00840733101557statID Pro COVID-19/Flu External ControlsMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00840733101564statID Pro COVID-19/Flu A&BMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
00850078377227iHealthiHealth Labs Inc.SCA2026-01-30
00810107290033Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
10850078377224iHealthIHEALTH LAB INC.SCA2026-01-30
10197344173587MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
20197344173584MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
00895160002960Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
00850078377098iHealthiHealth Labs Inc.SCA2026-01-02
00850078377104iHealthiHealth Labs Inc.SCA2026-01-02
00850078377128iHealthiHealth Labs Inc.SCA2026-01-02
00850078377135iHealthiHealth Labs Inc.SCA2026-01-02
10850078377095iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377101iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377125iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377132iHealthIHEALTH LAB INC.SCA2026-01-02
00850010224381CareSuperb COVID-19/FluA&B Antigen Combo Home TestAccess Bio Inc.SCA2025-12-24
10612479277936McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
40612479277944McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
00810107290224Flowflex Plus RSV + Flu A/B + COVID Home TestAcon Laboratories, Inc.SCA2025-11-06
30014613340751QuickVue™ WONDFO USA CO., LTD.SCA2025-10-31
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestINBIOS INTERNATIONAL, INCSCA2025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestINBIOS INTERNATIONAL, INCSCA2025-10-06