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Elecsys T4 Assay

Primary DI
04015630912728
Brand
Elecsys T4 Assay
Company
Roche Diagnostics GmbH
Model
12017709122
Catalog number
12017709122
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDXRadioimmunoassay, total thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961490000ELECSYS T4 ASSAYBoehringer Mannheim Corp.1996-06-13CDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630912728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630912728040156309127284015630912728

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
00850054026484QMedix™Diagnostic Automation, Inc.CDX2024-01-31
04048474045680T-4 Total ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDX2023-08-31
00840239045591Mycoplasma hominis IgG ELISADRG International IncCDX2023-08-25
00840239045683T-4 Total ELISADRG International IncCDX2023-08-25
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.CDX2022-10-26
07613336171660Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
07613336171677Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
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
00816870023090T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023106Monobind AccuLite T4 CLIA Kit - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023113T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870023120T4 AccuLite CLIA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870023137T4 SBS AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023144T4 SBS AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00630414599984Atellica IM T4Siemens Healthcare Diagnostics Inc.CDX2018-02-06
00630414599991Atellica IM T4 DILSiemens Healthcare Diagnostics Inc.CDX2018-02-06
04015630939800Elecsys T4Roche Diagnostics GmbHCDX2017-04-21
00817830022467Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022474Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022481Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20