FDA.reportPublic FDA data

ADVIA Centaur® Systems, ACS:180® Systems PHNB Calibrator

Primary DI
00630414527208
Brand
ADVIA Centaur® Systems, ACS:180® Systems PHNB Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10322092
Catalog number
5190965
Device description
Phenobarbital - CENTAUR - CAL - 2x2x2mL
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
DLZENZYME IMMUNOASSAY, PHENOBARBITAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011303000RANDOX PHENOBARBITALRandox Laboratories, Ltd.2001-07-02DLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414527208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414527208006304145272086304145272080630414527208

GMDN Terms#

Term, Definition table
TermDefinition
Phenobarbital 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 central nervous system drug phenobarbital in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store upright
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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00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
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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
00842768015397Dimension Vista® 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
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00630414561929ADVIA® Chemistry PHNB_2 Phenobarbital_2 ReagentsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
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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
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