FDA.reportPublic FDA data

iHealth

Primary DI
10850044118059
Brand
iHealth
Company
IHEALTH LAB INC.
Model
ICO-3000
Published
2022-09-30
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
GKPInstrument, Coagulation, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKPInstrument, Coagulation, AutomatedHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044118059PackageGS11In Commercial Distribution
20850044118056PackageGS15In Commercial Distribution
30850044118053PackageGS136In Commercial Distribution
00850044118052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004411805910850044118059
2085004411805620850044118056
3085004411805330850044118053
00850044118052008500441180528500441180520850044118052

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054953337
Device count
1
DM exempt
false
Premarket exempt
true
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
10850078377132iHealthICR-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195226000528ACL TOP 770INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000535ACL TOP 770 LASINSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000542ACL TOP 770sINSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000559ACL TOP 570INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000566ACL TOP 370INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
04987562516797CA CAL SSYSMEX CORPORATIONGKP2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONGKP2024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660SYSMEX CORPORATIONGKP2024-02-22
10850044118042iHealthIHEALTH LAB INC.GKP2022-09-30
08426950452867HemosIL Reference EmulsionINSTRUMENTATION LABORATORY COMPANYGKP2020-04-09
08426950928027ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2018-05-28
00842768012198Behring Coagulation CupSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
00842768014444BCS® System Cuvette RotorsSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
04987562205936CA CAL SSYSMEX CORPORATIONGKP2017-10-06
00842768008023BC Validation KitSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
00630414945514BCS® XP SystemSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
08426950003106HemosIL Sample DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950055990HemosIL Cleaning Solution (Clean A)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950062295HemosIL Factor DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950075899Cuvettes (2400 cuvettes)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497059ACL AcuStar cuvettes (1400 pcs)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784074ACL TOP 750INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784081ACL TOP 350 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950927990ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950451600ACL TOP CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950453499ACL TOP 500 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497974ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497981ACL TOP 700 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497998ACL TOP 700 LASINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950556916ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23