FDA.reportPublic FDA data

Atellica CH Total Protein_2

Primary DI
00630414654010
Brand
Atellica CH Total Protein_2
Company
Siemens Healthcare Diagnostics Inc.
Model
11645755
Catalog number
11645755
Device description
Atellica CH Total Protein (TP_2) RGT 3700T
Published
2026-03-18
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
CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414654010PrimaryGS10
00630414322070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414654010006304146540106304146540100630414654010
00630414322070006304143220706304143220700630414322070

GMDN Terms#

Term, Definition table
TermDefinition
Total protein IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total protein 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
DM exempt
true
Premarket exempt
true
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
00850053916144IDG/SanzayIDG/SANZAY CorporationCEK2024-01-12
00630414611082Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
00630414306025Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002201Teco Diagnostics Total Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002218Teco Diagnostics Total Protein Reagent Kit for TC-MatrixTECO DIAGNOSTICSCEK2023-11-14
06971674862215BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862222BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862239BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862246BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862253BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862260BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862277BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862284BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862291BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862307BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862314BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862321BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862338BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862352BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862369BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862376BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862383BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
05055273206531TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206555TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206562TOTAL PROTEIN 2 (TP 2)RANDOX LABORATORIES LIMITEDCEK2022-10-05
00380740155469ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155476ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155261AlinityABBOTT IRELANDCEK2022-06-30
00380740155278AlinityABBOTT IRELANDCEK2022-06-30