AIMSCREEN TCA

Basic Information

• Brand Name: AIMSCREEN TCA
• Primary DI: 00695684442255
• Version / Model: 44225
• Company Name: GERMAINE LABORATORIES, INC
• Labeler DUNS: 176458115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-05-04
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 99340880-8032-4ccc-a996-e4c9a5a0f381

Device Description

Lateral flow immunoassay for the detection of Tricyclic antidepresants (TCA) in urine.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30524	Tricyclic antidepressant 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 tricyclic antidepressant drugs 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	00695684442255	GS1
Unit of Use	00695684442251	GS1