Atellica IM Cor

Primary DI
00630414294155
Brand
Atellica IM Cor
Company
Siemens Healthcare Diagnostics Inc.
Model
11206248
Catalog number
11206248
Device description
Cortisol - Atellica IM - RGT 250T
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFTFLUOROMETRIC, CORTISOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFTFluorometric, CortisolClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142723000ADVIA Centaur Cortisol (COR) AssySiemens Healthcare Diagnostics, Inc.2015-03-31JFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293608PrimaryGS10
00630414294155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293608006304142936086304142936080630414293608
00630414294155006304142941556304142941550630414294155

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol 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
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
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
07613336180778Elecsys Cortisol IIIRoche Diagnostics GmbHJFT2025-07-24
00630414598666Atellica IM Cor MCMSiemens Healthcare Diagnostics Inc.JFT2020-09-24
00630414293608Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2020-05-31
00380740130053AlinityAbbott Ireland DiagnosticsJFT2018-08-10
00380740130060AlinityAbbott Ireland DiagnosticsJFT2018-08-10
04015630939985Elecsys Cortisol IIRoche Diagnostics GmbHJFT2018-06-06
00630414598642Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2018-02-06
00630414598659Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2018-02-06
00630414598673Atellica Cort Urine Recon BufferSiemens Healthcare Diagnostics Inc.JFT2018-02-06
14560189210735ST AIA-PACK CORTTOSOH CORPORATIONJFT2016-09-24
04560189211698AIA-PACK CORT Calibrator SetTOSOH CORPORATIONJFT2016-09-24
04560189211704AIA-PACK CORT Sample Diluting SolutionTOSOH CORPORATIONJFT2016-09-24
00630414121819ADVIA Centaur Cortisol Urine Reconstitution BufferSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414524610ADVIA Centaur® COR +ESiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414524740ADVIA Centaur® COR MCMSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414602943ADVIA Centaur® CORSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414602950ADVIA Centaur® COR +ESiemens Healthcare Diagnostics Inc.JFT2016-09-24
04015630940677Elecsys Cortisol IIRoche Diagnostics GmbHJFT2016-09-20
03573026551469VIDAS® Serum FreeBIOMERIEUX SAJFT2016-08-31
03573026097295VIDAS® Serum FreeBIOMERIEUX SAJFT2016-08-31
00380740016258ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016265ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016272ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06