FDA.reportPublic FDA data

Elecsys Tg II

Primary DI
07613336217696
Brand
Elecsys Tg II
Company
Roche Diagnostics GmbH
Model
09744967190
Catalog number
09744967190
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07613336217696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336217696076133362176967613336217696

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.

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
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

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
07613336169582Elecsys Tg IIRoche Diagnostics GmbHMSW2023-10-31
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