FDA.reportPublic FDA data

PHT

Primary DI
05055273206418
Brand
PHT
Company
RANDOX LABORATORIES LIMITED
Model
TD3409
Catalog number
TD3409
Device description
The device is intended for the quantitative in vitro determination of Phenytoin 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
DIPEnzyme Immunoassay, Diphenylhydantoin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIPEnzyme Immunoassay, DiphenylhydantoinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011393000RANDOX PHENYTOINRandox Laboratories, Ltd.2001-12-04DIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273206418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273206418050552732064185055273206418

GMDN Terms#

Term, Definition table
TermDefinition
Phenytoin 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 phenytoin (e.g., dilantin) 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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336121474ONLINE TDM PhenytoinRoche Diagnostics GmbHDIP2020-03-05
07613336157787ONLINE TDM PhenytoinRoche Diagnostics GmbHDIP2020-03-05
00380740135515AlinityABBOTT LABORATORIESDIP2018-12-04
00630414596037Atellica CH PhnySiemens Healthcare Diagnostics Inc.DIP2017-12-19
00842768005619Dimension® Flex® reagent cartridge PTNSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00842768015410Dimension Vista® Flex® reagent cartridge PTNSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00842768017384Syva® Emit® 2000 Phenytoin AssaySiemens Healthcare Diagnostics Inc.DIP2016-09-24
00842768017391Syva® Emit® 2000 Phenytoin CalibratorsSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00842768023217Emit® 2000 Phenytoin AssaySiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414121758ADVIA Centaur® PHTN MCMSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414121765ADVIA Centaur® Systems, ACS:180® Systems PHTN CalibratorSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414121772ADVIA Centaur® PHTN CalibratorSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414209128ADVIA Centaur® PHTNSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414209135ADVIA Centaur® PHTNSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414561936ADVIA® Chemistry PHNY_2 Phenytoin_2 ReagentsSiemens Healthcare Diagnostics Inc.DIP2016-09-24
00630414953410IMMULITE® Systems SDC CONTROL Serum Drug Control ModuleSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDIP2016-09-24
00630414961903IMMULITE® 2000 Systems PHN PhenytoinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDIP2016-09-24
00630414964492IMMULITE®/IMMULITE® 1000 Systems PHN PhenytoinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDIP2016-09-24
04015630997138ONLINE TDM PhenytoinRoche Diagnostics GmbHDIP2016-09-20
04015630997763PhenytoinRoche Diagnostics GmbHDIP2016-09-20
04015630999378PhenytoinRoche Diagnostics GmbHDIP2016-09-20
00884883001220CEDIA Phenytoin II AssayMicrogenics CorporationDIP2016-09-12
10758750004690VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIP2016-08-26
15099590232030SynchronBeckman Coulter, Inc.DIP2016-08-24
00380740001797ARCHITECTABBOTT LABORATORIESDIP2016-06-06
00380740001803ARCHITECTABBOTT LABORATORIESDIP2016-06-06
00380740102708ARCHITECTABBOTT LABORATORIESDIP2016-06-06