FDA.reportPublic FDA data

QMS Vancomycin Immunoassay

Primary DI
00884883012837
Brand
QMS Vancomycin Immunoassay
Company
Microgenics Corporation
Model
10017224
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K050419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050419000QMS VANCOMYCINSeradyn, Inc.2005-04-01LEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883012837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883012837008848830128378848830128370884883012837

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA 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 a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27

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
00630414561967ADVIA® Chemistry VANC_2 Vancomycin_2 ReagentsSiemens Healthcare Diagnostics Inc.LEH2016-09-24
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