FDA.reportPublic FDA data

IMMULITE® 2000 Systems PHE Phenobarbital

Primary DI
00630414961828
Brand
IMMULITE® 2000 Systems PHE Phenobarbital
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381542
Catalog number
L2KPB2
Device description
Phenobarbital - IMMULITE - RGT - 200 Tests
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
DLZENZYME IMMUNOASSAY, PHENOBARBITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLZEnzyme Immunoassay, PhenobarbitalClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970227000IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERDpc Cirrus1997-04-08JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414961828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414961828006304149618286304149618280630414961828

GMDN Terms#

Term, Definition table
TermDefinition
Phenobarbital 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 phenobarbital 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
10758750004560VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DLZ2021-11-08
07613336121467ONLINE TDM PhenobarbitalRoche Diagnostics GmbHDLZ2020-03-05
00380740154110AlinityABBOTT LABORATORIESDLZ2018-11-12
00630414595993Atellica CH PhnbSiemens Healthcare Diagnostics Inc.DLZ2017-12-22
05055273206401PHBRANDOX LABORATORIES LIMITEDDLZ2016-09-24
00842768005596Dimension® Flex® reagent cartridge PHNOSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768015397Dimension Vista® Flex® reagent cartridge PHNOSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768017407Syva® Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768017414Syva® Emit® 2000 Phenobarbital CalibratorsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768023224Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527192ADVIA Centaur® PHNBSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527208ADVIA Centaur® Systems, ACS:180® Systems PHNB CalibratorSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527215ADVIA Centaur® Systems Phenobarbital CalibratorSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414561929ADVIA® Chemistry PHNB_2 Phenobarbital_2 ReagentsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414964379IMMULITE®/IMMULITE® 1000 Systems PHE PhenobarbitalSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDLZ2016-09-24
04015630997060ONLINE TDM PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
04015630999316PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
04015630999323PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
00884883001237CEDIA Phenobarbital II AssayMicrogenics CorporationDLZ2016-09-12
00380740001773ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
00380740001780ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
00380740102692ARCHITECTABBOTT LABORATORIESDLZ2016-06-06