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
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
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
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
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