FDA.reportPublic FDA data

iHealth

Primary DI
50850044118064
Brand
iHealth
Company
iHealth Labs Inc.
Model
ICO-3000
Published
2022-09-30
Public version status
Update
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
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233842000iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc.2024-05-31QYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60850044118061PackageGS136In Commercial Distribution
50850044118064PrimaryGS10
00850044118069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6085004411806160850044118061
5085004411806450850044118064
00850044118069008500441180698500441180690850044118069

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
6
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
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
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
00850044118687iHealthKD-7232026-07-14

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