FDA.reportPublic FDA data

Atellica CH Ca

Primary DI
00630414654041
Brand
Atellica CH Ca
Company
Siemens Healthcare Diagnostics Inc.
Model
11645759
Catalog number
11645759
Device description
Calcium CPC( Ca) Atellica CH - RGT 1780T
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CICCRESOLPHTHALEIN COMPLEXONE, CALCIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CICCresolphthalein Complexone, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991576000ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.1999-06-30CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414654041PrimaryGS10
00630414322117Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414654041006304146540416304146540410630414654041
00630414322117006304143221176304143221170630414322117

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
2
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
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31
00630414293752Atellica IM SHBG11206215112062152020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053916076IDG/SanzayIDG/SANZAY CorporationCIC2024-01-15
10673486001365Teco Diagnostics Calcium Reagent SetTECO DIAGNOSTICSCIC2023-07-25
00811727016065Pointe Calcium ReagentHORIBA INSTRUMENTS INCORPORATEDCIC2021-01-30
00630414550916ADVIA® Chemistry Multi-Drug Urine Controls 1,2Siemens Healthcare Diagnostics Inc.CIC2020-09-24
00811727015754Pointe Calcium Arsenazo for BS480HORIBA INSTRUMENTS INCORPORATEDCIC2020-05-28
00852169008119ClearChem Diagnostics Inc. CalciumCLEARCHEM DIAGNOSTICS INC.CIC2018-04-30
00630414595672Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2017-12-21
00817274022559JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2017-06-09
00812137011923Calcium Arsenazo III ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIC2016-10-12
00817439020345Calcium / BS480Medtest Dx, Inc.CIC2016-09-27
15099590010126AUBeckman Coulter, Inc.CIC2016-09-24
15099590020057AUBeckman Coulter, Inc.CIC2016-09-24
00842768014123Dimension® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00842768015618Dimension Vista® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00657498000625Calcium (CPC) LiquiColor®STANBIO LABORATORY, L.P.CIC2016-09-24
00630414508405ADVIA® Chemistry Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414538716ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPCSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414555904ADVIA® Chemistry CPC Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
04015630901999CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921348CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921355CalciumRoche Diagnostics GmbHCIC2016-09-20
05060500090432Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090449Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090456Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05055273200898CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200911CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200928CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
00817274021088JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021095JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021101JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09