Status Toxi Cup

Basic Information

• Brand Name: Status Toxi Cup
• Primary DI: 00868348000256
• Version / Model: 65C13+4
• Company Name: Lifesign L.L.C.
• Labeler DUNS: 010964864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-17
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: fb7293dd-529f-49dc-9aa0-c281ece12057

Device Description

Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55463	Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10868348000253	GS1	Kit Box	25	In Commercial Distribution
Primary	00868348000256	GS1

Premarket Submissions

Submission Number	Supplement Number
K071489	000
K122064	000
K130275	000