FDA.reportPublic FDA data

iHealth

Primary DI
00856362005906
Brand
iHealth
Company
iHealth Labs Inc.
Model
ICO-3000
Published
2022-09-16
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
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856362005903PackageGS11In Commercial Distribution
20856362005900PackageGS15In Commercial Distribution
30856362005907PackageGS136In Commercial Distribution
50856362005901PackageGS15In Commercial Distribution
60856362005908PackageGS136In Commercial Distribution
00856362005906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085636200590310856362005903
2085636200590020856362005900
3085636200590730856362005907
5085636200590150856362005901
6085636200590860856362005908
00856362005906008563620059068563620059060856362005906

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. 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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856362005814iHealthPT12021-04-01
00850044118656iHealthICF-3000P2026-05-15
00850078377180iHealthICR-30002026-05-15
00850078377272iHealthCSW-ANSCR2026-05-15
00850044118427iHealthICF-30002024-05-25
00850044118434iHealthICF-30002024-05-24
00850044118458iHealthICF-30002024-05-24
00856362005890iHealthICO-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
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.QYT2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCQYT2026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00050428101735CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2025-08-08
00816862027402WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
10816862027409WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
00194346415908equateWAL-MART STORES, INC.QYT2025-05-22
10194346415905equateWAL-MART STORES, INC.QYT2025-05-22
00816862027280WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
10816862027287WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
06930251802365equateWAL-MART STORES, INC.QYT2025-04-05
16930251802362equateWAL-MART STORES, INC.QYT2025-04-05
00816862026252WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026276WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026290WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026259WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026273WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026297WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026238WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
00816862026177WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
10816862026235WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
30014613340188CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2024-11-20
00850042559666CorDx TyfastCORETESTS, INC.QYT2024-09-05
00850042559925CorDx TyfastCORETESTS, INC.QYT2024-09-05