FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems PHN Phenytoin

Primary DI
00630414964492
Brand
IMMULITE®/IMMULITE® 1000 Systems PHN Phenytoin
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381510
Catalog number
LKPN1
Device description
Phenytoin - IMMULITE - RGT - 100 Tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K000006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000006000IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.2000-02-28DIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414964492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414964492006304149644926304149644920630414964492

GMDN Terms#

Term, Definition table
TermDefinition
Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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