FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge PHNO

Primary DI
00842768015397
Brand
Dimension Vista® Flex® reagent cartridge PHNO
Company
Siemens Healthcare Diagnostics Inc.
Model
10445124
Catalog number
K4060
Device description
Phenobarbital Flex® reagent cartridge, 80 tests
Published
2016-09-24
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
DLZENZYME IMMUNOASSAY, PHENOBARBITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLZEnzyme Immunoassay, PhenobarbitalClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051087000DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc.2005-07-11JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015397PrimaryGS10
00630414004952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015397008427680153978427680153970842768015397
00630414004952006304140049526304140049520630414004952

GMDN Terms#

Term, Definition table
TermDefinition
Phenobarbital IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phenobarbital in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
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00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
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
10758750004560VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DLZ2021-11-08
07613336121467ONLINE TDM PhenobarbitalRoche Diagnostics GmbHDLZ2020-03-05
00380740154110AlinityABBOTT LABORATORIESDLZ2018-11-12
00630414595993Atellica CH PhnbSiemens Healthcare Diagnostics Inc.DLZ2017-12-22
05055273206401PHBRANDOX LABORATORIES LIMITEDDLZ2016-09-24
00842768005596Dimension® Flex® reagent cartridge PHNOSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768017407Syva® Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768017414Syva® Emit® 2000 Phenobarbital CalibratorsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768023224Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527192ADVIA Centaur® PHNBSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527208ADVIA Centaur® Systems, ACS:180® Systems PHNB CalibratorSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527215ADVIA Centaur® Systems Phenobarbital CalibratorSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414561929ADVIA® Chemistry PHNB_2 Phenobarbital_2 ReagentsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414961828IMMULITE® 2000 Systems PHE PhenobarbitalSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDLZ2016-09-24
00630414964379IMMULITE®/IMMULITE® 1000 Systems PHE PhenobarbitalSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDLZ2016-09-24
04015630997060ONLINE TDM PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
04015630999316PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
04015630999323PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
00884883001237CEDIA Phenobarbital II AssayMicrogenics CorporationDLZ2016-09-12
00380740001773ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
00380740001780ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
00380740102692ARCHITECTABBOTT LABORATORIESDLZ2016-06-06