FDA.reportPublic FDA data

QMS Tobramycin Assay

Primary DI
00884883012691
Brand
QMS Tobramycin Assay
Company
Microgenics Corporation
Model
10017109
Published
2016-09-12
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
LCRFluorescent Immunoassay, Tobramycin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCRFluorescent Immunoassay, TobramycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060998000QMS TOBRAMYCINSeradyn, Inc.2006-07-21LCR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883012691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883012691008848830126918848830126910884883012691

GMDN Terms#

Term, Definition table
TermDefinition
Tobramycin 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 tobramycin 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
04260759931253VenSure Light Balloon Dilation SystemFiagon GmbHLCR2022-10-14
00380740154141AlinityABBOTT LABORATORIESLCR2018-12-12
00630414595962Atellica CH TobSiemens Healthcare Diagnostics Inc.LCR2017-12-22
00884883011328QMS Tobramycin Immunoassay Calibrator SetMicrogenics CorporationLCR2016-10-25
00842768005381Dimension® Flex® reagent cartridge TOBRSiemens Healthcare Diagnostics Inc.LCR2016-09-24
00842768015472Dimension Vista® Flex® reagent cartridge TOBRSiemens Healthcare Diagnostics Inc.LCR2016-09-24
15099590222185SynchronBeckman Coulter, Inc.LCR2016-08-24
00380740013127ARCHITECTABBOTT LABORATORIESLCR2016-06-06
00817470009521VENTERASmith & Nephew, Inc.LCR2015-12-06