FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740011192
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
6L28-20
Catalog number
06L2820
Device description
Tricyclic Antidepressants
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K983268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961393000TRICYCLICS SERUM TOX ASSAYDiagnostic Reagents, Inc.1996-06-12LFH
K983268000MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYDiagnostic Reagents, Inc.1998-11-18LFH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740011192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740011192003807400111923807400111920380740011192

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740017460ARCHITECT8K28-0208K28022016-06-06
00380740017477ARCHITECT8K28-1108K28112016-06-06
00380740017484ARCHITECT8K28-2708K28272016-06-06
00380740017491ARCHITECT8K28-3508K28352016-06-06
00380740081911ARCHITECT1P06-0201P06022016-09-09
00380740019730ARCHITECT9D96-2109D96212016-06-06
00380740225742ARCHITECT08G983008G98302026-10-14
00380740225759ARCHITECT04J623004J62302026-10-14
00380740019747ARCHITECT9D97-2109D97212016-06-06
00380740000202ARCHITECT1E01-2101E01212016-06-06
00380740019761ARCHITECT9D99-2109D99212016-06-06
00380740138738ARCHITECT6P30-2106P30212016-09-09
00380740225575ARCHITECT04P553104P55312026-08-22
00380740138783Alinity09P710109P71012023-11-16
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414595849TD TRICYC ANTIDEPRESSANT ASSAY, TCASiemens Healthcare Diagnostics Inc.LFH2018-12-01
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