FDA.reportPublic FDA data

CEDIA Carbamazepine II Assay

Primary DI
00884883001251
Brand
CEDIA Carbamazepine II Assay
Company
Microgenics Corporation
Model
100006
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
KLTEnzyme Immunoassay, Carbamazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLTEnzyme Immunoassay, CarbamazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914857000CEDIA(R) CARBAMAZEPINE ASSAYMicrogenics Corp.1992-01-15KLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883001251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883001251008848830012518848830012510884883001251

GMDN Terms#

Term, Definition table
TermDefinition
Carbamazepine 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 central nervous system drug carbamazepine in a clinical specimen, using an enzyme immunoassay (EIA) 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
07613336121108ONLINE TDM Carbamazepine Gen.4Roche Diagnostics GmbHKLT2020-03-05
00380740135331AlinityABBOTT LABORATORIESKLT2019-12-09
00630414595986Atellica CH CarbSiemens Healthcare Diagnostics Inc.KLT2017-12-27
05055273206463CBZRANDOX LABORATORIES LIMITEDKLT2016-09-24
00842768000928Syva® Emit® Carbamazepine AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768000935Syva® Emit® Carbamazepine CalibratorsSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768001871Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768001888Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768005770Dimension® Flex® reagent cartridge CRBMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768014352Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768015137Dimension Vista® Flex® reagent cartridge CRBMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768023231Emit® 2000 Carbamazepine AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527130ADVIA Centaur® CARBSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527147ADVIA Centaur® CARB +ZSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527178ADVIA Centaur® CARB MCMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414560793ADVIA® Chemistry CARB_2 ReagentsSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414961095IMMULITE® 2000 Systems CMP CarbamazepineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLT2016-09-24
00630414963679IMMULITE® / IMMULITE® 1000 Systems CMP CarbamazepineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLT2016-09-24
04015630936885ONLINE TDM Carbamazepine Gen4Roche Diagnostics GmbHKLT2016-09-20
04015630999033CarbamazepineRoche Diagnostics GmbHKLT2016-09-20
00380740001834ARCHITECTAbbott GmbHKLT2016-09-09
00380740081072ARCHITECTAbbott GmbHKLT2016-09-09
00380740081935ARCHITECTAbbott GmbHKLT2016-09-09
15099590232184SynchronBeckman Coulter, Inc.KLT2016-08-24
10758750005185VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLT2016-08-10
00380740102685ARCHITECTABBOTT LABORATORIESKLT2016-06-06