FDA.reportPublic FDA data

Elecsys CalSet T4

Primary DI
04015630912711
Brand
Elecsys CalSet T4
Company
Roche Diagnostics GmbH
Model
12017717122
Catalog number
12017717122
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
04015630912711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630912711040156309127114015630912711

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen.

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
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04048474045680T-4 Total ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDX2023-08-31
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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
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00816870021225N-T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021232N-T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
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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
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00816870021690T4 SBS AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
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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
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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
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