FDA.reportPublic FDA data

Atellica IM Calibrator D

Primary DI
00630414293561
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOJKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
LOKKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOJKit, Test,Alpha-Fetoprotein For Testicular CancerImmunology2
LOKKit, Test, Alpha-Fetoprotein For Neural Tube DefectsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020806000
P930036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020806000ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAYBayer Corp.2002-03-27LOJ
P930036000ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590744403Access AFPBeckman Coulter, Inc.LOK2025-11-10
07613336217146Elecsys AFPRoche Diagnostics GmbHLOJ2024-10-22
07613336172025Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-07
07613336206157Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
07613336206164Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
10758750034819VITROSORTHO CLINICAL DIAGNOSTICSLOJ2022-10-24
00630414294117Atellica 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
00816870020426Monobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020433AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870020440AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870020457AFP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870020464AFP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020884AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020891AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870021843AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022109AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022116AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870022123AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870022130AFP AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022147Monobind AccuLite AFP CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022543Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022550AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870023281AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
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