FDA.reportPublic FDA data

iFlash-FT3

Primary DI
06925912718482
Brand
iFlash-FT3
Company
Shenzhen YHLO Biotech Co., Ltd.
Model
C86018
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KHQRadioassay, Triiodothyronine Uptake

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHQRadioassay, Triiodothyronine UptakeClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925912718482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925912718482069259127184826925912718482

GMDN Terms#

Term, Definition table
TermDefinition
Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free triiodothyronine (FT3) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420735989
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925912718512iFlash-T4C860262022-10-26
06925912718703iFlash-HCGC860122024-01-30
06925912718833iFlash-Anti-Beta2-Glycoprotein IC89027Z2023-12-31
06925912710424Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61112022-10-26
06925912710547Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61062022-10-26
06925912719205iFlash-Mycoplasma pn. IgMC88004M2022-10-26
06925912715290iFlash-Cleaning SolutionC899232022-10-26
06925912716044Wash BufferC800012022-10-26
06925912716075Trigger Solution (1×)C899982022-10-26
06925912716099Trigger Solution (1×)C899482022-10-26
06925912716105Pre-Trigger Solution (1×)C899992022-10-26
06925912716112Pre-Trigger Solution (1×)C899592022-10-26
06925912716129Pre-Trigger Solution (1×)C899492022-10-26
06925912716587Sample DiluentC899112022-10-26
06925912716600Sample DiluentC899122022-10-26
06925912716624Sample DiluentC899142022-10-26
06925912716631Sample DiluentC899152022-10-26
06925912716648Sample DiluentC899172022-10-26
06925912716679Sample DiluentC899182022-10-26
06925912716693Sample DiluentC899192022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474032673T3-Uptake ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKHQ2023-08-29
10758750033843VITROSORTHO CLINICAL DIAGNOSTICSKHQ2023-03-28
14560189212135ST AIA-PACK T-UTOSOH CORPORATIONKHQ2019-07-25
04560189212121AIA-PACK T-U CALIBRATOR SETTOSOH CORPORATIONKHQ2019-07-25
14560189212128AIA-PACK T-U CALIBRATOR SETTOSOH CORPORATIONKHQ2019-07-25
24560189212132ST AIA-PACK T-UTOSOH CORPORATIONKHQ2019-07-25
00840239032676T3-Uptake ELISADRG International IncKHQ2019-03-20
00816870021591T3 Uptake AccuBind ELISA Test System - 96 WellsMONOBIND, INC.KHQ2019-02-11
00816870021607T3 Uptake AccuBind ELISA Test System - 192 WellsMONOBIND, INC.KHQ2019-02-11
00816870023038T3 Uptake AccuLite CLIA Test System - 96 WellsMONOBIND, INC.KHQ2019-02-11
00816870023045T3 Uptake AccuLite CLIA Test System - 192 WellsMONOBIND, INC.KHQ2019-02-11
00380740131548AlinityAbbott Ireland DiagnosticsKHQ2018-10-22
00630414600246Atellica IM TupSiemens Healthcare Diagnostics Inc.KHQ2018-02-06
00630414600253Atellica IM TupSiemens Healthcare Diagnostics Inc.KHQ2018-02-06
04015630940530Elecsys T-UptakeRoche Diagnostics GmbHKHQ2017-04-14
00817830022566T3 Uptake 125I RIA 200 Tube KitMP BIOMEDICALS, LLCKHQ2017-01-09
00817830022429T3 Uptake 125I RIA KitMP BIOMEDICALS, LLCKHQ2016-10-20
00884883003453DRI T-Uptake Microgenics CorporationKHQ2016-10-03
00842768005695Dimension® Flex® reagent cartridge TUSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00842768015496Dimension Vista® Flex® reagent cartridge TUSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00884883005556DRI T-Uptake Calibrator KitMicrogenics CorporationKHQ2016-09-24
00630414177120ADVIA Centaur® TupSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00630414177137ADVIA Centaur® TupSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
04015630899579Elecsys Tuptake AssayRoche Diagnostics GmbHKHQ2016-09-20
04015630916030TUptakeRoche Diagnostics GmbHKHQ2016-09-20
00884883005662CEDIA T Uptake Microgenics CorporationKHQ2016-09-12
10758750009145VITROSORTHO CLINICAL DIAGNOSTICSKHQ2016-08-26
00380740003517ARCHITECTABBOTT LABORATORIESKHQ2016-06-06
00380740042523ARCHITECTABBOTT LABORATORIESKHQ2016-06-06