FDA.reportPublic FDA data

Elecsys Tg II

Primary DI
07613336169582
Brand
Elecsys Tg II
Company
Roche Diagnostics GmbH
Model
08906564190
Catalog number
08906564190
Published
2023-10-31
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
MSWSystem, test, thyroglobulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSWSystem, Test, ThyroglobulinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221890000Elecsys Tg IIRoche Diagnostics2023-09-30MSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336169582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336169582076133361695827613336169582

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroglobulin 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
00630414238418Atellica IM TgSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2025-09-22
00630414238425Atellica IM TgSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2025-09-22
15099590754501Access ThyroglobulinBeckman Coulter, Inc.MSW2023-12-01
07613336203569Elecsys Tg IIRoche Diagnostics GmbHMSW2023-10-31
00630414953199IMMULITE® Systems GAS CONTROL GastrinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2020-09-24
00816870021768Tg AccuBind ELISA Test System - 96 WellsMONOBIND, INC.MSW2019-02-11
00816870021775Tg AccuBind ELISA Test System - 192 WellsMONOBIND, INC.MSW2019-02-11
00816870023205Monobind AccuLite Tg CLIA Kit - 96 WellsMONOBIND, INC.MSW2019-02-11
00816870023212Tg AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MSW2019-02-11
00630414954301IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414954318IMMULITE® 2000 Systems TG Thyroglobulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414954523IMMULITE® Systems TG Recovery Sample ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414972077IMMULITE®/IMMULITE® 1000 Systems TG ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414972084IMMULITE® 2000 Systems TG ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414978345IMMULITE® Systems TG CONTROL ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
15099590225858Access Thyroglobulin Sample DiluentBeckman Coulter, Inc.MSW2016-09-09
15099590227166Access Thyroglobulin CalibratorsBeckman Coulter, Inc.MSW2016-09-09
15099590227173Access ThyroglobulinBeckman Coulter, Inc.MSW2016-09-09
04260157631106B.R.A.H.M.S Tg-pluS RIAB.R.A.H.M.S GmbHMSW2016-08-17