TRICYCLICS LEVEL 2 V2

Basic Information

• Brand Name: TRICYCLICS LEVEL 2 V2
• Primary DI: B800TCAL2V2SMAYO0
• Version / Model: TCA L2 V2 S MAYO
• Catalog Number: TCA L2 V2 S MAYO
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-17
• Public Version: 1
• Public Version Date: 2023-01-25
• Public Version Status: New
• Public Device Record Key: 2a3360da-ac52-4881-a2fe-e1a40d94abe9

Device Description

TRICYCLICS LEVEL 2 V2

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: Yes
• 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
62933	Multiple antidepressant therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of antidepressant drugs from multiple classes [e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), tetracyclic antidepressants (TeCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B800TCAL2V2SMAYO5	HIBCC	Box	81	In Commercial Distribution
Primary	B800TCAL2V2SMAYO0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius