FDA.reportPublic FDA data

iHealth

Primary DI
10850078377132
Brand
iHealth
Company
IHEALTH LAB INC.
Model
ICR-3000
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850078377132PackageGS15In Commercial Distribution
20850078377139PackageGS136In Commercial Distribution
00850078377135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007837713210850078377132
2085007837713920850078377139
00850078377135008500783771358500783771350850078377135

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054953337
Device count
1
DM exempt
false
Premarket exempt
false
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
10850078377224iHealthICR-30002026-01-30
10850078377095iHealthICR-30002026-01-02
10850078377101iHealthICR-30002026-01-02
10850078377125iHealthICR-30002026-01-02
10850044118691iHealthPT2L2025-12-19
10850044118707iHealthPT9L2025-12-19
10850044118721iHealthPT9L2025-12-19
10850044118776iHealthBG5S2025-12-19
10850044118806iHealthAG-6072025-12-19
10850078377088iHealthKN-550BT2025-12-19
10856362005156iHealthBG5SKIT2025-12-19
10856362005392iHealthKN-550BT2025-12-19
10850044118967iHealthBP-300CL2025-12-10
10856362005149iHealthBP5S2025-03-03
10850044118844iHealth3.6g*902024-11-18
10850044118868iHealthANC12024-10-30
10850044118783iHealthF50432024-09-28
10850044118233iHealthBG5SKIT2024-05-28
10850044118240iHealthBG5SKIT2024-05-27
10850044118424iHealthICF-30002024-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078377180iHealthiHealth Labs Inc.SCA2026-05-15
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
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