FDA.reportPublic FDA data

IMMULITE® 2000 Systems THE Theophylline

Primary DI
00630414966311
Brand
IMMULITE® 2000 Systems THE Theophylline
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381539
Catalog number
L2KTN2
Device description
Theophyline - 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
KLSENZYME IMMUNOASSAY, THEOPHYLLINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLSEnzyme Immunoassay, TheophyllineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954569000IMMULITE THEOPHYLLINEDiagnostic Products Corp.1995-11-13KLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414966311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414966311006304149663116304149663110630414966311

GMDN Terms#

Term, Definition table
TermDefinition
Theophylline 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 anti-asthma drug theophylline 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
07613336147931ONLINE TDM TheophyllineRoche Diagnostics GmbHKLS2020-03-05
00380740154127AlinityABBOTT LABORATORIESKLS2019-01-02
00630414596006Atellica CH TheoSiemens Healthcare Diagnostics Inc.KLS2017-12-22
05055273206432THEORANDOX LABORATORIES LIMITEDKLS2016-09-24
00842768001024Syva® Emit® 2000 Theophylline AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768001031Syva® Emit® 2000 Theophylline CalibratorsSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768001413Syva® Emit® Caffeine AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768005664Dimension® Flex® reagent cartridge THEOSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768015458Dimension Vista® Flex® reagent cartridge THEOSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768023286Emit® 2000 Theophylline AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460918ADVIA Centaur® Systems Calibrator 27Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460956ADVIA Centaur® THEO 2Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460963ADVIA Centaur® THEO 2Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414561905ADVIA® Chemistry THEO_2 Theophylline_2 ReagentsSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414966571IMMULITE®/IMMULITE® 1000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
04015630997169ONLINE TDM TheophyllineRoche Diagnostics GmbHKLS2016-09-20
04015630999934TheophyllineRoche Diagnostics GmbHKLS2016-09-20
00884883001275CEDIA Theophylline II AssayMicrogenics CorporationKLS2016-09-12
10758750004706VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-26
10758750008759VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-26
15099590232078SynchronBeckman Coulter, Inc.KLS2016-08-24
10758750006779VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-23
00380740102715ARCHITECTABBOTT LABORATORIESKLS2016-06-06