FDA.reportPublic FDA data

Atellica IM PTH

Primary DI
00630414599441
Brand
Atellica IM PTH
Company
Siemens Healthcare Diagnostics Inc.
Model
10995621
Catalog number
10995621
Device description
Intact Parathyroid Hormone (iPTH) Atellica IM - RGT 190T
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
CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEWRadioimmunoassay, Parathyroid HormoneClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163658000ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.2017-05-23CEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414599441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599441006304145994416304145994410630414599441

GMDN Terms#

Term, Definition table
TermDefinition
Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] 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
00816870020402PTH Intact AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870023731PTH Whole & Intact AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870023748PTH Whole & Intact AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870023755PTH Whole & Intact AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870023762PTH Whole & Intact AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870024516PTH Intact AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870024523PTH Intact AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
07613336170304Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336217542Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336224922Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336224939Elecsys PTH STATRoche Diagnostics GmbHCEW2024-07-30
10758750032709VITROSORTHO CLINICAL DIAGNOSTICSCEW2024-01-20
20758750032706VITROSORTHO CLINICAL DIAGNOSTICSCEW2024-01-20
04048474036459PTH (Parathyroid) Intact ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEW2023-08-31
00630414954035IMMULITE® 2000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEW2020-09-24
00083059070224Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.CEW2020-07-01
00630414293745Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2020-05-31
00380740156244ARCHITECTAbbott GmbHCEW2020-03-03
00850002253115Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00850002253122Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00850002253139Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00840239036452PTH (Parathyroid) Intact ELISADRG International IncCEW2019-03-20
00630414592398ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-11-12
00380740136215AlinityAbbott GmbHCEW2018-10-24
00630414592336ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414592343ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414592381ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414599458Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2018-02-06
B24221IPTHUE010PTH (Intact, 1-84) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CEW2017-08-03
04015630939787Elecsys PTHRoche Diagnostics GmbHCEW2017-04-21