Atellica IM Calibrator D

Primary DI
00630414294117
Brand
Atellica IM Calibrator D
Company
Siemens Healthcare Diagnostics Inc.
Model
11206244
Catalog number
11206244
Device description
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
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
LOKKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOKKit, Test, Alpha-Fetoprotein For Neural Tube DefectsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020806000ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAYBayer Corp.2002-03-27LOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293561PrimaryGS10
00630414294117Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293561006304142935616304142935610630414293561
00630414294117006304142941176304142941170630414294117

GMDN Terms#

Term, Definition table
TermDefinition
Multiple tissue-associated protein/tumour marker IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright
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
6
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
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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
15099590744403Access AFPBeckman Coulter, Inc.LOK2025-11-10
00630414293561Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2020-05-31
00380740130794AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130800AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130817AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130824AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00630414238791Atellica IM AFPSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414238807Atellica IM AFPSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414597720Atellica IM AFP MCMSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414598369Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2017-12-27
00630414598376Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2017-12-27
00630414022963ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2016-07-12
00380740112400ARCHITECTAbbott Ireland DiagnosticsLOK2014-12-19
00380740081287ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
00380740081294ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
00380740081317ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
06438147321315AutoDELFIA hAFP KitWallac OyLOK2014-09-24
06438147321322AutoDELFIA hAFP kitWallac OyLOK2014-09-24
00630414124797ADVIA Centaur® Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414124940ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCMSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414177328ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414177335ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414953519IMMULITE®/IMMULITE®1000 Systems AF AFP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414961033IMMULITE® 2000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414961040IMMULITE® 2000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414963594IMMULITE®/IMMULITE®1000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
H628332111Access AFPBeckman Coulter, Inc.LOK2014-09-16
H628332161Access AFP Sample DiluentBeckman Coulter, Inc.LOK2014-09-16