FDA.reportPublic FDA data

ADVIA® Chemistry VANC_2 Vancomycin_2 Reagents

Primary DI
00630414561967
Brand
ADVIA® Chemistry VANC_2 Vancomycin_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10377509
Catalog number
10377509
Device description
Vancomycin - ADVIA Chem. - RGT - 4x100 tests
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
LEHRADIOIMMUNOASSAY, VANCOMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEHRadioimmunoassay, VancomycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020692000EMIT 2000 VANCOMYCIN ASSAYDade Behring, Inc.2002-05-10LEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414561967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414561967006304145619676304145619670630414561967

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug vancomycin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
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
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
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24
00630414177038ADVIA Centaur® TSH10309959103099592016-09-24
00630414556093ADVIA Centaur® SHBG Calibrator10285318102853182016-09-24
00630414559704ADVIA Centaur® T3 MCM10361928103619282016-09-24
00630414574516ADVIA® Chemistry Hemoglobin A1c_3 Calibrators10491408104914082016-09-24
00630414579160ADVIA Centaur® iPTH10492369104923692016-09-24
00630414585345ADVIA Centaur® iPTH10493615104936152016-09-24
00630414585352ADVIA Centaur® iPTH10493616104936162016-09-24
00630414587486ADVIA Centaur® iPTH Calibrator10630628106306282016-09-24
00630414587882ADVIA Centaur® Systems VitD Calibrator10630911106309112016-09-24
00630414600611ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents10916067109160672016-09-24
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336121627ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHLEH2020-03-05
07613336157800ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHLEH2020-03-05
00380740156237ARCHITECTAbbott GmbHLEH2020-03-03
00380740135348AlinityABBOTT LABORATORIESLEH2018-11-07
00630414596020Atellica CH VancSiemens Healthcare Diagnostics Inc.LEH2017-12-19
04015630934416ONLINE TDM Vancomyin Gen.3Roche Diagnostics GmbHLEH2016-10-13
04015630934447ONLINE TDM Vancomyin Gen.3Roche Diagnostics GmbHLEH2016-10-13
00842768001109Syva® Emit® 2000 Vancomycin AssaySiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768005763Dimension® Flex® reagent cartridge VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768015533Dimension Vista® Flex® reagent cartridge VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768023323Emit® 2000 Vancomycin AssaySiemens Healthcare Diagnostics Inc.LEH2016-09-24
00884883011182QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-09-24
00630414121444ADVIA Centaur® Systems, ACS:180® Systems VANC CalibratorSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414121451ADVIA Centaur® Vancomycin CalibratorSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414126111ADVIA Centaur® VANC MCMSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414203928ADVIA Centaur® VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414443096ADVIA Centaur® VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00884883012837QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-09-22
04015630915996VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630997978Vancomycin ONLINE TDM VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630998920VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630999392VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630997961Vancomycin ONLINE TDM VancomycinRoche Diagnostics GmbHLEH2016-09-20
10758750006731VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LEH2016-08-26
00884883011243QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-08-26
15099590223342SynchronBeckman Coulter, Inc.LEH2016-08-24
00380740001711ARCHITECTAbbott GmbHLEH2016-06-06
00380740009847ARCHITECTABBOTT LABORATORIESLEH2016-06-06
00380740105327ARCHITECTAbbott GmbHLEH2016-06-06