FDA.reportPublic FDA data

iFlash-T4

Primary DI
06925912718512
Brand
iFlash-T4
Company
Shenzhen YHLO Biotech Co., Ltd.
Model
C86026
Published
2022-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CDXRadioimmunoassay, Total Thyroxine
KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2
KLIEnzyme Immunoassay, Non-Radiolabeled, Total ThyroxineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925912718512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925912718512069259127185126925912718512

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) 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
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
06925912716792Sample DiluentC89919-12022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590754488Access Total T4 IIBeckman Coulter, Inc.KLI2025-09-19
00816870023489T4 High Sensitivity AccuBind ELISA Test System - 96 wellsMONOBIND, INC.KLI2024-09-13
00816870024851T4 High Sensitivity AccuBind ELISA Test System - 192 wellsMONOBIND, INC.KLI2024-09-13
00850049545983QMedix™Diagnostic Automation, Inc.KLI2024-02-02
00850054026484QMedix™Diagnostic Automation, Inc.CDX2024-01-31
04048474052794Total Thyroxine (tT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-09-01
04048474041095Free Thyroxine (fT4) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-31
04048474045680T-4 Total ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDX2023-08-31
04048474017816Total Thyroxine (T4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-26
00840239045591Mycoplasma hominis IgG ELISADRG International IncCDX2023-08-25
00840239045683T-4 Total ELISADRG International IncCDX2023-08-25
00840239052797Total Thyroxine (tT4) ELISADRG International IncKLI2023-08-25
00894175000893AccuDiag ™Diagnostic Automation, Inc.KLI2023-06-14
07613336171660Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
07613336171677Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
00725609000649SPOTCHECKASTORIA-PACIFIC, INC.KLI2020-12-17
00850392007077BioCheck T4 EIA Test KitBIOCHECK, INC.KLI2019-10-08
00840239041098Free Thyroxine (fT4) ELISADRG International IncKLI2019-06-10
00840239017819Total Thyroxine (T4) ELISADRG International IncKLI2019-03-20
00816870021218N-T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021225N-T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021232N-T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870021249N-T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870021256N-T4 AccuBind ELISA Test System - 1920 WellsMONOBIND, INC.CDX2019-02-11
00816870021652T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021669T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021676T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870021683T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870021690T4 SBS AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021706T4 SBS AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11