FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740102708
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
5P08-21
Catalog number
05P0821
Device description
Phenytoin
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K945725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945725000PHENYTION EIA TESTDiagnostic Reagents, Inc.1995-02-03DIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740102708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740102708003807401027083807401027080380740102708

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
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

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
05055273206418PHTRANDOX LABORATORIES LIMITEDDIP2016-09-24
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