Beckman Coulter C82914

GUDID 00894354002397

Psychiatry Clozapine Assay Kit

SALADAX BIOMEDICAL, INC.

Clozapine IVD, reagent

• Primary Device ID: 00894354002397
• NIH Device Record Key: 486a31b1-0dbc-4375-8233-2c16e37897c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beckman Coulter
• Version Model Number: C82914
• Catalog Number: C82914
• Company DUNS: 144379539
• Company Name: SALADAX BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com
• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com
• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com
• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com
• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com
• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com
• Phone: +1 (610) 419-6731
• Email: Techsupport@saladax.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894354002397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190028

FDA Product Code

• QKT: Clozapine Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

On-Brand Devices [Beckman Coulter]

• 00894354002397: Psychiatry Clozapine Assay Kit
• 00894354002373: Psychiatry Control Kit 2
• 00894354002366: Psychiatry Calibrator Kit 2