FDA.reportPublic FDA data

ONLINE TDM Theophylline

Primary DI
07613336147931
Brand
ONLINE TDM Theophylline
Company
Roche Diagnostics GmbH
Model
08253153190
Catalog number
08253153190
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K020740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020740000ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.2002-04-16KLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336147931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336147931076133361479317613336147931

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336246436cobas ultra controller10856653001108566530012026-11-05
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00630414966311IMMULITE® 2000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
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