FDA.reportPublic FDA data

TD TRICYC ANTIDEPRESSANT ASSAY, TCA

Primary DI
00630414595849
Brand
TD TRICYC ANTIDEPRESSANT ASSAY, TCA
Company
Siemens Healthcare Diagnostics Inc.
Model
11097528
Catalog number
11097528
Device description
TD TRICYC ANTIDEPRESSANT ASSAY, TCA
Published
2018-12-01
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
LFHU.V. Spectrometry, tricyclic antidepressant drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961393000TRICYCLICS SERUM TOX ASSAYDiagnostic Reagents, Inc.1996-06-12LFH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414595849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414595849006304145958496304145958490630414595849

GMDN Terms#

Term, Definition table
TermDefinition
Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs 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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
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
00868348000256Status Toxi CupLifesign L.L.C.LFH2017-05-17
10868348000253Status Toxi CupLifesign L.L.C.LFH2017-05-17
00816565020960Fastect II Drug Screen Dipstick TestAMEDITECH INC.LFH2017-03-31
00748349000311QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-27
00748349000274QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-24
00748349000243QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-12-13
00748349000199QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
20748349000193QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
00748349000175QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
20748349000179QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
00748349000106QuikScreen Multi 11 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-04
00748349000113QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
20748349000117QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
10864040000331QTEST 11 (25 pack)MEDIMPEX UNITED, INCLFH2016-09-30
10864040000348QTEST 12 (25 Pack)MEDIMPEX UNITED, INCLFH2016-09-30
00863480002106LifeSign QuikScreen 11Lifesign L.L.C.LFH2016-09-24
00863480002113Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00842768001277Syva® RapidTest d.a.u.® TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
20863480002117Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00630414551036ADVIA® Chemistry TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
10763924086532ACCUTEST - 5 Drug Test Cup *CLIA-Waived*JANT PHARMACAL CORPORATIONLFH2016-09-23
10763924087539ACCUTEST - 6 Drug CupJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924811530ACCUTEST Drug Test Cup 11-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924822536ACCUTEST Drug Test Cup 12-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924823533ACCUTEST Drug Test Cup 13-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
00817405020010Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020027Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020126Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19
00817405020171Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19
00884883001183DRI Tricyclics Serum Tox AssayMicrogenics CorporationLFH2016-09-12