FDA.reportPublic FDA data

Elecsys FT4 IV

Primary DI
07613336172780
Brand
Elecsys FT4 IV
Company
Roche Diagnostics GmbH
Model
09043284190
Catalog number
09043284190
Published
2023-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CECRADIOIMMUNOASSAY, FREE THYROXINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220456000Elecsys FT4 IVRoche Diagnostics2023-04-07CEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336172780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336172780076133361727807613336172780

GMDN Terms#

Term, Definition table
TermDefinition
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590780982Access Free T4Beckman Coulter, Inc.CEC2024-03-12
00850049545990QMedix™Diagnostic Automation, Inc.CEC2024-02-02
04048474042665Free Thyroxine (fT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEC2023-08-31
00894175000923AccuDiag ™Diagnostic Automation, Inc.CEC2023-06-14
07613336175071Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-03
06947145577971MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
06947145577988MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
00630414293851Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414294292Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414599144Atellica IM FT4 MCMSiemens Healthcare Diagnostics Inc.CEC2020-09-24
00630414293684Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00630414294193Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00840239042668Free Thyroxine (fT4) ELISADRG International IncCEC2019-06-10
00816870021713Free T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870021720Free T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870021737Monobind AccuBind Free T4 ELISA Kit - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870021744Free T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CEC2019-02-11
00816870023151Free T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870023168Free T4 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870023175Free T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870023182Monobind AccuLite Free T4 CLIA Kit - 960 WellsMONOBIND, INC.CEC2019-02-11
00380740121822AlinityABBOTT IRELANDCEC2018-07-31
00380740121815AlinityABBOTT IRELANDCEC2018-05-31
00380740119799ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119805ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119812ARCHITECTABBOTT IRELANDCEC2018-05-14
08809317540382FREND Free T4NanoEnTek, Inc.CEC2018-05-04
00630414599120Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599137Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599977Atellica IM T4Siemens Healthcare Diagnostics Inc.CEC2018-02-06