T-Cup® Compact

Basic Information

• Brand Name: T-Cup® Compact
• Primary DI: 00817405020560
• Version / Model: ACDOA-6125
• Catalog Number: ACDOA-6125
• Company Name: Instant Technologies, Inc.
• Labeler DUNS: 019410187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-23
• Public Version: 8
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: aa292052-cf0c-43d6-bb88-a8bf5ae462a3

Device Description

T-Cup® Compact Multi-Drug Urine Test Cup <AMP1000, BAR300, BUP10, BZO300, COC300, mAMP1000, MDMA500, MOP300, MTD300, OXY100, PCP25, THC50>

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	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
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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
Primary	00817405020560	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius