FDA.reportPublic FDA data

Syva® Emit® Methotrexate Assay

Primary DI
00842768001383
Brand
Syva® Emit® Methotrexate Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445368
Catalog number
6L119UL
Device description
Syva® Emit® Methotrexate Assay
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K811459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811459000EMIT-AND METHOTREXATE ASSAYSyva Co.1981-06-09LAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768001383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768001383008427680013838427680013830842768001383

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.

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(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
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00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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
07613336224823ONLINE TDM Methotrexate Roche Diagnostics GmbHLAO2024-03-25
00812101030639ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2020-08-31
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