Beckman Coulter C82914

GUDID 00894354002397

Psychiatry Clozapine Assay Kit

SALADAX BIOMEDICAL, INC.

Clozapine IVD, reagent Clozapine IVD, reagent Clozapine IVD, reagent Clozapine IVD, reagent Clozapine IVD, reagent Clozapine IVD, reagent 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