FDA.reportPublic FDA data

CBZ

Primary DI
05055273206463
Brand
CBZ
Company
RANDOX LABORATORIES LIMITED
Model
TD3416
Catalog number
TD3416
Device description
For the quantitative in vitro determination of Carbamazepine in human serum
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K011648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011648000RANDOX CARBAMAZEPINERandox Laboratories, Ltd.2002-01-15KLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273206463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273206463050552732064635055273206463

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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
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
15099590232184SynchronBeckman Coulter, Inc.KLT2016-08-24
10758750005185VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLT2016-08-10
00380740102685ARCHITECTABBOTT LABORATORIESKLT2016-06-06