FDA.reportPublic FDA data

Atellica CH Cholinesterase_2

Primary DI
00630414611044
Brand
Atellica CH Cholinesterase_2
Company
Siemens Healthcare Diagnostics Inc.
Model
11537221
Catalog number
11537221
Device description
Cholinestrase (CHE_2) Atellica CH
Published
2023-06-29
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
DIHColorimetry, cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIHColorimetry, CholinesteraseClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414611044PrimaryGS10
00630414305042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414611044006304146110446304146110440630414611044
00630414305042006304143050426304143050420630414305042

GMDN Terms#

Term, Definition table
TermDefinition
Pseudocholinesterase IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme pseudocholinesterase in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
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
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414482446ADVIA® Chemistry LIP Lipase Reagents10311896103118962020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase Reagents10315176103151762020-09-24
00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010612200Test-mate ChE Cholinesterase Test SystemEqm Research, Inc.DIH2023-07-31
00860010612217AChE Assay KitEqm Research, Inc.DIH2023-07-31
00860010612224PChE Assay KitEqm Research, Inc.DIH2023-07-31
10673486001488Teco Diagnostics Cholinesterase Reagent SetTECO DIAGNOSTICSDIH2023-07-26
06971674862932BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862949BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862956BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862963BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862970BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862987BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862994BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863007BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863014BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863021BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863038BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863045BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863052BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
00630414305042Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
08800055732985ARENA StarARUM DENTISTRY Co., Ltd.DIH2023-03-31
04015630991549CholinesteraseRoche Diagnostics GmbHDIH2021-06-28
04015630920945Cholinesterase Gen.2Roche Diagnostics GmbHDIH2021-01-18
00630414465401ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414596273Atellica CH CHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768014178Dimension® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768015373Dimension Vista® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
10758750000241VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
10758750004225VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
07613336133620Cholinesterase Gen.2Roche Diagnostics GmbHDIH2020-03-05
05055273201093BUTYRYL CHOLINESTERASE (CHE)RANDOX LABORATORIES LIMITEDDIH2019-06-03