FDA.reportPublic FDA data

Atellica CH Trig_2

Primary DI
00630414610955
Brand
Atellica CH Trig_2
Company
Siemens Healthcare Diagnostics Inc.
Model
11537222
Catalog number
11537222
Device description
Triglycerides_2 (Trig_2) Atellica CH Assay 2000 Tests
Published
2022-07-08
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
CDTLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414610955PrimaryGS10
00630414305110Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414610955006304146109556304146109550630414610955
00630414305110006304143051106304143051100630414305110

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of triglycerides 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
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486002225Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
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