AccessGUDID - DEVICE: Status Toxi Cup 13+4 (00863480002113)

GUDID

Device Identifier (DI) Information

Brand Name: Status Toxi Cup 13+4
Version or Model: 65C12+4
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Lifesign L.L.C.

Primary DI Number: 00863480002113
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 010964864 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs
LCM	Enzyme Immunoassay, Phencyclidine
DJG	Enzyme Immunoassay, Opiates
DJC	Thin Layer Chromatography, Methamphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ	Enzyme Immunoassay, Cannabinoids
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate
DKZ	Enzyme Immunoassay, Amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071489	000
K122064	000
K130275	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6714c35-5419-43ff-8eea-02e12413aee8
Public Version Date: July 06, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20863480002117	4	10863480002110	2017-06-01	Not in Commercial Distribution	Shipper Box
10863480002110	25	00863480002113	2017-06-01	Not in Commercial Distribution	Kit Box