Detectabuse

Basic Information

• Brand Name: Detectabuse
• Primary DI: 00810042681323
• Version / Model: Custom QC16
• Catalog Number: Custom QC16
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• Labeler DUNS: 028007698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-06
• Public Version: 2
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: 8e1072d1-e974-445c-bce1-23d0baee4e78
• Distribution End Date: 2023-10-11

Device Description

Detectabuse Custom Liquid Control Synthetic Urine 20mL

Device Characteristics

• Single Use: No
• 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
DIF	Drug Mixture Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55461	Multiple drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042681323	GS1