FDA.reportPublic FDA data

ADVIA Centaur Calcitonin

Primary DI
00630414284736
Brand
ADVIA Centaur Calcitonin
Company
Siemens Healthcare Diagnostics Inc.
Model
11420589
Catalog number
11420589
Device description
ADVIA Centaur Calcitonin (CALCT) 100T Kit
Published
2019-07-05
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
JKRRADIOIMMUNOASSAY, CALCITONIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKRRadioimmunoassay, CalcitoninClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182012000ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited2018-12-21JKR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414284736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414284736006304142847366304142847360630414284736

GMDN Terms#

Term, Definition table
TermDefinition
Calcitonin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcitonin in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336171509Elecsys CalcitoninRoche Diagnostics GmbHJKR2026-06-01
07613336188064Elecsys CalcitoninRoche Diagnostics GmbHJKR2026-06-01
00816870023694Calcitonin AccuLite CLIA Test System -192 WellsMONOBIND, INC.JKR2024-09-13
00816870023700Calcitonin AccuLite CLIA Test System - 96 WellsMONOBIND, INC.JKR2024-09-13
00816870023717Calcitonin AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JKR2024-09-13
00816870023724Calcitonin AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JKR2024-09-13
04048474036480Calcitonin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKR2023-08-31
00083059070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.JKR2020-07-01
00630414284743Atellica IM CalcitoninSiemens Healthcare Diagnostics Inc.JKR2019-07-05
00840239036483Calcitonin ELISADRG International IncJKR2019-06-10
00850002253153Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.JKR2019-05-20
B24221CALHUE010Calcitonin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKR2017-08-03
04015630940158Elecsys CalcitoninRoche Diagnostics GmbHJKR2017-04-21
08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.JKR2016-12-07
00630414953120IMMULITE® Systems CONTROL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414953618IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414961156IMMULITE® 2000 Systems CAL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414963730IMMULITE / IMMULITE® 1000 Systems CAL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
04015630934799Elecsys Calcitonin ImmunoassayRoche Diagnostics GmbHJKR2016-09-20
30014613333937MicroVueQUIDEL CORPORATIONJKR2016-09-15