FDA.reportPublic FDA data

ADVIA Centaur® Systems Calibrator 27

Primary DI
00630414460918
Brand
ADVIA Centaur® Systems Calibrator 27
Company
Siemens Healthcare Diagnostics Inc.
Model
10310432
Catalog number
128304
Device description
Theophylline - CENTAUR - CAL - 2x2x5mL
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLSENZYME IMMUNOASSAY, THEOPHYLLINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLSEnzyme Immunoassay, TheophyllineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013272000ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.2001-10-25KLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414460918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414460918006304144609186304144609180630414460918

GMDN Terms#

Term, Definition table
TermDefinition
Theophylline therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
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

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Primary DI, Brand, Model table
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00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
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00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
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00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147931ONLINE TDM TheophyllineRoche Diagnostics GmbHKLS2020-03-05
00380740154127AlinityABBOTT LABORATORIESKLS2019-01-02
00630414596006Atellica CH TheoSiemens Healthcare Diagnostics Inc.KLS2017-12-22
05055273206432THEORANDOX LABORATORIES LIMITEDKLS2016-09-24
00842768001024Syva® Emit® 2000 Theophylline AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768001031Syva® Emit® 2000 Theophylline CalibratorsSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768001413Syva® Emit® Caffeine AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768005664Dimension® Flex® reagent cartridge THEOSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768015458Dimension Vista® Flex® reagent cartridge THEOSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768023286Emit® 2000 Theophylline AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460956ADVIA Centaur® THEO 2Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460963ADVIA Centaur® THEO 2Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414561905ADVIA® Chemistry THEO_2 Theophylline_2 ReagentsSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414966311IMMULITE® 2000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
00630414966571IMMULITE®/IMMULITE® 1000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
04015630997169ONLINE TDM TheophyllineRoche Diagnostics GmbHKLS2016-09-20
04015630999934TheophyllineRoche Diagnostics GmbHKLS2016-09-20
00884883001275CEDIA Theophylline II AssayMicrogenics CorporationKLS2016-09-12
10758750004706VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-26
10758750008759VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-26
15099590232078SynchronBeckman Coulter, Inc.KLS2016-08-24
10758750006779VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-23
00380740102715ARCHITECTABBOTT LABORATORIESKLS2016-06-06