FDA.reportPublic FDA data

Atellica™ CH ASTP5P

Primary DI
00630414596426
Brand
Atellica™ CH ASTP5P
Company
Siemens Healthcare Diagnostics Inc.
Model
11097599
Catalog number
11097599
Device description
Aspartate Aminotransferase P5P (ASTP5P) - Atellica™ CH - RGT - 1684T
Published
2018-12-01
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
CITNadh oxidation/nad reduction, ast/sgot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CITNadh Oxidation/Nad Reduction, Ast/SgotClinical 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
00630414596426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596426006304145964266304145964260630414596426

GMDN Terms#

Term, Definition table
TermDefinition
Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total aspartate aminotransferase (AST) in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent Preparation Step
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
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336130537Aspartate Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCIT2024-01-12
00850053916038IDG/SanzayIDG/SANZAY CorporationCIT2024-01-05
06971674861850BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861867BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861874BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861881BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861898BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861904BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861911BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861928BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861935BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861942BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861959BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861966BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861973BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861980BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861997BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674862000BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674862017BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674862024BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
10673486001150AST/SGOT LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCIT2023-07-20
10673486001167AST (SGOT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCIT2023-07-20
10673486001174AST (SGOT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCIT2023-07-20
10673486001181AST (SGOT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCIT2023-07-20
00380740155735ARCHITECTABBOTT IRELANDCIT2022-06-14
00380740155759ARCHITECTABBOTT IRELANDCIT2022-06-14
00380740158057AlinityABBOTT IRELANDCIT2022-06-14
00380740158064AlinityABBOTT IRELANDCIT2022-06-14
00380740170011ARCHITECTABBOTT IRELANDCIT2022-05-24
00380740170028ARCHITECTABBOTT IRELANDCIT2022-05-24