FDA.reportPublic FDA data

ONLINE TDM Theophylline

Primary DI
04015630997169
Brand
ONLINE TDM Theophylline
Company
Roche Diagnostics GmbH
Model
3531066190
Catalog number
3531066190
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
04015630997169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630997169040156309971694015630997169

GMDN Terms#

Term, Definition table
TermDefinition
Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA 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 nephelometry/turbidimetry method.

Storage And Handling#

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

Regulatory Flags#

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

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04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
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07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
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07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
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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
00630414966311IMMULITE® 2000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
00630414966571IMMULITE®/IMMULITE® 1000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
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