Beckman Coulter

Basic Information

• Brand Name: Beckman Coulter
• Primary DI: 00894354002397
• Version / Model: C82914
• Catalog Number: C82914
• Company Name: SALADAX BIOMEDICAL, INC.
• Labeler DUNS: 144379539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-15
• Public Version: 1
• Public Version Date: 2022-06-23
• Public Version Status: New
• Public Device Record Key: 486a31b1-0dbc-4375-8233-2c16e37897c6

Device Description

Psychiatry Clozapine Assay Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
QKT	Clozapine Test System	Clinical Chemistry	862.3245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55561	Clozapine IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of clozapine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894354002397	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN190028	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius