FDA.reportPublic FDA data

ONLINE TDM Methotrexate

Primary DI
07613336224823
Brand
ONLINE TDM Methotrexate
Company
Roche Diagnostics GmbH
Model
09230815190
Catalog number
09230815190
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LAOEnzyme immunoassay, methotrexate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAOEnzyme Immunoassay, MethotrexateUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233454000ONLINE TDM MethotrexateRoche Diagnostics Operations2024-02-20LAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336224823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336224823076133362248237613336224823

GMDN Terms#

Term, Definition table
TermDefinition
Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antineoplastic drug methotrexate in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
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
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812101031162ARK™ Methotrexate II AssayARK DIAGNOSTICS INCLAO2024-10-24
00812101031179ARK™ Methotrexate II AssayARK DIAGNOSTICS INCLAO2024-10-24
00812101031186ARK™ Methotrexate II CalibratorARK DIAGNOSTICS INCLAO2024-10-24
00812101031193ARK™ Methotrexate II ControlARK DIAGNOSTICS INCLAO2024-10-24
00812101031209ARK™ Methotrexate II ControlARK DIAGNOSTICS INCLAO2024-10-24
00812101031216ARK™ Methotrexate II ControlARK DIAGNOSTICS INCLAO2024-10-24
00812101031223ARK™ Methotrexate II Dilution BufferARK DIAGNOSTICS INCLAO2024-10-24
07613336224816ONLINE TDM MethotrexateRoche Diagnostics GmbHLAO2024-03-25
00812101030639ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2020-08-31
00842768001383Syva® Emit® Methotrexate AssaySiemens Healthcare Diagnostics Inc.LAO2016-09-24
00858724003056ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2016-09-24
00858724003216ARK™ Methotrexate Assay (c-pack)ARK DIAGNOSTICS INCLAO2016-09-24
00858724003254ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2016-09-24
00380740011611ABBOTTABBOTT LABORATORIESLAO2016-09-09
00380740011628ABBOTTABBOTT LABORATORIESLAO2016-09-09
00380740011635ABBOTTABBOTT LABORATORIESLAO2016-09-09