FDA.reportPublic FDA data

Atellica IM Tup

Primary DI
00630414600253
Brand
Atellica IM Tup
Company
Siemens Healthcare Diagnostics Inc.
Model
10995712
Catalog number
10995712
Device description
T Uptake (Tup) Atellica IM - RGT 50T
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHQRADIOASSAY, TRIIODOTHYRONINE UPTAKE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHQRadioassay, Triiodothyronine UptakeClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970539000CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.1997-03-24KHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600253006304146002536304146002530630414600253

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid uptake (T-uptake) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative determination of thyroid hormone uptake (T-uptake), or the unbound/free portion of thyroxine binding globulin (TBG) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474032673T3-Uptake ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKHQ2023-08-29
10758750033843VITROSORTHO CLINICAL DIAGNOSTICSKHQ2023-03-28
06925912718482iFlash-FT3Shenzhen YHLO Biotech Co., Ltd.KHQ2022-10-26
14560189212135ST AIA-PACK T-UTOSOH CORPORATIONKHQ2019-07-25
04560189212121AIA-PACK T-U CALIBRATOR SETTOSOH CORPORATIONKHQ2019-07-25
14560189212128AIA-PACK T-U CALIBRATOR SETTOSOH CORPORATIONKHQ2019-07-25
24560189212132ST AIA-PACK T-UTOSOH CORPORATIONKHQ2019-07-25
00840239032676T3-Uptake ELISADRG International IncKHQ2019-03-20
00816870021591T3 Uptake AccuBind ELISA Test System - 96 WellsMONOBIND, INC.KHQ2019-02-11
00816870021607T3 Uptake AccuBind ELISA Test System - 192 WellsMONOBIND, INC.KHQ2019-02-11
00816870023038T3 Uptake AccuLite CLIA Test System - 96 WellsMONOBIND, INC.KHQ2019-02-11
00816870023045T3 Uptake AccuLite CLIA Test System - 192 WellsMONOBIND, INC.KHQ2019-02-11
00380740131548AlinityAbbott Ireland DiagnosticsKHQ2018-10-22
00630414600246Atellica IM TupSiemens Healthcare Diagnostics Inc.KHQ2018-02-06
04015630940530Elecsys T-UptakeRoche Diagnostics GmbHKHQ2017-04-14
00817830022566T3 Uptake 125I RIA 200 Tube KitMP BIOMEDICALS, LLCKHQ2017-01-09
00817830022429T3 Uptake 125I RIA KitMP BIOMEDICALS, LLCKHQ2016-10-20
00884883003453DRI T-Uptake Microgenics CorporationKHQ2016-10-03
00842768005695Dimension® Flex® reagent cartridge TUSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00842768015496Dimension Vista® Flex® reagent cartridge TUSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00884883005556DRI T-Uptake Calibrator KitMicrogenics CorporationKHQ2016-09-24
00630414177120ADVIA Centaur® TupSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00630414177137ADVIA Centaur® TupSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
04015630899579Elecsys Tuptake AssayRoche Diagnostics GmbHKHQ2016-09-20
04015630916030TUptakeRoche Diagnostics GmbHKHQ2016-09-20
00884883005662CEDIA T Uptake Microgenics CorporationKHQ2016-09-12
10758750009145VITROSORTHO CLINICAL DIAGNOSTICSKHQ2016-08-26
00380740003517ARCHITECTABBOTT LABORATORIESKHQ2016-06-06
00380740042523ARCHITECTABBOTT LABORATORIESKHQ2016-06-06