Home GUDID 20863480002117 Status Toxi Cup 13+4
Primary DI 20863480002117
Brand Status Toxi Cup 13+4
Company Lifesign L.L.C.
Model 65C12+4
Device description Status Toxi-Cup 13 panel drug cup with 4 adulterants: AMP1000 BAR300 COC300 THC50 MAD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TCA1000 BUP10 Adulterants - CRE, pH, SG, NBP
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10863480002110 Package GS1 25 Not in Commercial Distribution 20863480002117 Package GS1 4 Not in Commercial Distribution 00863480002113 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10863480002110 10863480002110 20863480002117 20863480002117 00863480002113 00863480002113 863480002113 0863480002113
GMDN Terms# Term, Definition table Term Definition Drug/toxicology adulteration IVD, kit, enzyme spectrophotometry, rapid A collection of reagents and other associated materials intended to be used for the qualitative detection of drug and/or toxicology adulteration of a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. This test is commonly used in the laboratory or in point-of-care analyses.
Regulatory Flags# DUNS number 010964864 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00630414595849 TD TRICYC ANTIDEPRESSANT ASSAY, TCA Siemens Healthcare Diagnostics Inc. LFH 2018-12-01 00868348000256 Status Toxi Cup Lifesign L.L.C. LFH 2017-05-17 10868348000253 Status Toxi Cup Lifesign L.L.C. LFH 2017-05-17 00816565020960 Fastect II Drug Screen Dipstick Test AMEDITECH INC. LFH 2017-03-31 00748349000311 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2017-02-27 00748349000274 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2017-02-24 00748349000243 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2016-12-13 00748349000199 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2016-11-04 20748349000193 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2016-11-04 00748349000175 QuikScreen Multi 12 Drug Cup Test SYNTRON BIORESEARCH, INC. LFH 2016-10-21 20748349000179 QuikScreen Multi 12 Drug Cup Test SYNTRON BIORESEARCH, INC. LFH 2016-10-21 00748349000106 QuikScreen Multi 11 Drug Cup Test SYNTRON BIORESEARCH, INC. LFH 2016-10-04 00748349000113 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2016-10-04 20748349000117 QuikScreen SYNTRON BIORESEARCH, INC. LFH 2016-10-04 10864040000331 QTEST 11 (25 pack) MEDIMPEX UNITED, INC LFH 2016-09-30 10864040000348 QTEST 12 (25 Pack) MEDIMPEX UNITED, INC LFH 2016-09-30 00863480002106 LifeSign QuikScreen 11 Lifesign L.L.C. LFH 2016-09-24 00863480002113 Status Toxi Cup 13+4 Lifesign L.L.C. LFH 2016-09-24 00842768001277 Syva® RapidTest d.a.u.® TCA Siemens Healthcare Diagnostics Inc. LFH 2016-09-24 00630414551036 ADVIA® Chemistry TCA Siemens Healthcare Diagnostics Inc. LFH 2016-09-24 10763924086532 ACCUTEST - 5 Drug Test Cup *CLIA-Waived* JANT PHARMACAL CORPORATION LFH 2016-09-23 10763924087539 ACCUTEST - 6 Drug Cup JANT PHARMACAL CORPORATION LFH 2016-09-23 10763924811530 ACCUTEST Drug Test Cup 11-Panel CLIA-Waived JANT PHARMACAL CORPORATION LFH 2016-09-23 10763924822536 ACCUTEST Drug Test Cup 12-Panel CLIA-Waived JANT PHARMACAL CORPORATION LFH 2016-09-23 10763924823533 ACCUTEST Drug Test Cup 13-Panel CLIA-Waived JANT PHARMACAL CORPORATION LFH 2016-09-23 00817405020010 Alere iCup Dx 14 Instant Technologies, Inc. LFH 2016-09-19 00817405020027 Alere iCup Dx 14 Instant Technologies, Inc. LFH 2016-09-19 00817405020126 Alere iScreen Dx Instant Technologies, Inc. LFH 2016-09-19 00817405020171 Alere iScreen Dx Instant Technologies, Inc. LFH 2016-09-19 00884883001183 DRI Tricyclics Serum Tox Assay Microgenics Corporation LFH 2016-09-12