FDA.reportPublic FDA data

IMMULITE® Systems SDC CONTROL Serum Drug Control Module

Primary DI
00630414953410
Brand
IMMULITE® Systems SDC CONTROL Serum Drug Control Module
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10385397
Catalog number
SDCM
Device description
Serum Drug - IMMULITE - CTL - 2x5mL
Published
2016-09-24
Public version status
Update
Distribution status
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
00630414953410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414953410006304149534106304149534100630414953410

GMDN Terms#

Term, Definition table
TermDefinition
Multiple therapeutic drugs/drugs of abuse IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.

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
00630414964041IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-110381403103814032020-09-24
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

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
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