FDA.reportPublic FDA data

Atellica IM aTPO

Primary DI
00630414597942
Brand
Atellica IM aTPO
Company
Siemens Healthcare Diagnostics Inc.
Model
10995467
Catalog number
10995467
Device description
TPO Ab - Atellica IM - RGT 500T
Published
2017-12-22
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
JZOSYSTEM, TEST, THYROID AUTOANTIBODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003291000BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAYBayer Diagnostics Corp.2000-12-05JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597942PrimaryGS10
00630414007311Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597942006304145979426304145979420630414597942
00630414007311006304140073116304140073110630414007311

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase (anti-TPO); also known as anti-microsomal antibody, 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
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
5
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
07613336217764Elecsys Anti-TgRoche Diagnostics GmbHJZO2026-08-07
07613336217641Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2026-06-01
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414608754Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608761Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414609492Atellica IM aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608570ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414608747ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414609409ADVIA Centaur aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
15099590763527Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JZO2023-12-01
07613336171479Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
07613336203521Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
04048474033694TSH Receptor Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJZO2023-08-29
00840239037084Anti TG Ab ELISADRG International IncJZO2023-08-25
00840239033697TSH Receptor Autoantibody ELISA DRG International IncJZO2023-08-24
00840239035615Anti TPO Ab ELISADRG International IncJZO2023-08-24
B3507204500Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
B3507204600Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
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00813545026752MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
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00813545027162MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027179MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
07613336160305Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14