FDA.reportPublic FDA data

Synchron

Primary DI
15099590232184
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
469112
Catalog number
469112
Device description
Carbamazepine Reagent (CAR 2 x 100)
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K955644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955644000SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEMBeckman Instruments, Inc.1996-02-16KLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590232184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023218415099590232184

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
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

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
00884883001251CEDIA Carbamazepine II AssayMicrogenics CorporationKLT2016-09-12
00380740001834ARCHITECTAbbott GmbHKLT2016-09-09
00380740081072ARCHITECTAbbott GmbHKLT2016-09-09
00380740081935ARCHITECTAbbott GmbHKLT2016-09-09
10758750005185VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLT2016-08-10
00380740102685ARCHITECTABBOTT LABORATORIESKLT2016-06-06