FDA.reportPublic FDA data

QMS Lidocaine Immunoassay

Primary DI
00884883006072
Brand
QMS Lidocaine Immunoassay
Company
Microgenics Corporation
Model
0374686
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
KLREnzyme Immunoassay, Lidocaine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLREnzyme Immunoassay, LidocaineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090282000QMS LIDOCAINEThermo Fisher Scientific, Inc.2009-05-29KLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883006072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883006072008848830060728848830060720884883006072

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
00630414220680Atellica CH LIDOSiemens Healthcare Diagnostics Inc.KLR2018-10-08
00842768001390Syva® Emit® Lidocaine AssaySiemens Healthcare Diagnostics Inc.KLR2016-09-24
00842768001406Syva® Emit® Disopyramide AssaySiemens Healthcare Diagnostics Inc.KLR2016-09-24
00842768005305Dimension® Flex® reagent cartridge LIDOSiemens Healthcare Diagnostics Inc.KLR2016-09-24
00842768015281Dimension Vista® Flex® reagent cartridge LIDOSiemens Healthcare Diagnostics Inc.KLR2016-09-24
04015630915736LidocaineRoche Diagnostics GmbHKLR2016-09-20
04015630996933ONLINE TDM LidocaineRoche Diagnostics GmbHKLR2016-09-20