FDA.reportPublic FDA data

iHealth

Primary DI
00850044118069
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
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKPCoronavirus Antigen Detection Test System.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKPCoronavirus Antigen Detection Test System.UnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044118066PackageGS11In Commercial Distribution
20850044118063PackageGS16In Commercial Distribution
30850044118060PackageGS136In Commercial Distribution
00850044118069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004411806610850044118066
2085004411806320850044118063
3085004411806030850044118060
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
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
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
00850044118694iHealthPT2L2025-12-19
00850044118700iHealthPT9L2025-12-19
00850044118724iHealthPT9L2025-12-19
00850044118823iHealthKD-5811BT2026-04-15
00850044118830iHealthKD-5811BT2026-04-15
00850044118960iHealthBP-300CL2025-12-10
00850078377081iHealthKN-550BT2025-12-19
00855111003279iHealthPO32023-08-14
00855111003958iHealthBP3L2022-09-30
00856362005005iHealthKN-550BT2022-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B115ABCASS1CANAO25T1Advin COVID-19 Antigen Test @HomeADVIN BIOTECH, INC.QKP2025-12-29
50810172700074Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
60810172700071Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
00860013635107Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635114Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635121Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00197644204359Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644380435Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644563371Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00810143620184Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.QKP2025-01-13
00816862024609WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
10816862024606WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
00742860000027OSOM COVID-19 Antigen Rapid TestSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000034OSOM COVID-19 Antigen Control KitSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000041OSOM COVID-19 Antigen Home TestSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control KitSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo HomeSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
50810172700081Speedy Swab Rapid COVID-19 & FLU A&B Self-Test WatMIND USAQKP2024-08-30
50810172700098Speedy Swab Rapid COVID-19 & FLU A&B Self-Test WatMIND USAQKP2024-08-30
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08
00810172700079Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box)WatMIND USAQKP2024-08-08
00810172700086Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08
10810172700083RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10810172700090RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)WatMIND USAQKP2024-08-08
20810172700080RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
20810172700097RDB10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2024-08-08
30810172700087CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08
30810172700094CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)WatMIND USAQKP2024-08-08
40810172700084CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08