FDA.reportPublic FDA data

Atellica IM Cor MCM

Primary DI
00630414598666
Brand
Atellica IM Cor MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10995539
Catalog number
10995539
Device description
Cortisol (Cor) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Published
2020-09-24
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
JFTFLUOROMETRIC, CORTISOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFTFluorometric, CortisolClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143194000ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)Siemens Healthcare Diagnostics, Inc.2014-12-05JJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598666006304145986666304145986660630414598666

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, 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
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336180778Elecsys Cortisol IIIRoche Diagnostics GmbHJFT2025-07-24
00630414293608Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2020-05-31
00630414294155Atellica 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