MyCare Psychiatry MCP2-CAL-US

GUDID 00894354002304

Calibrator Kit 2

SALADAX BIOMEDICAL, INC.

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• Primary Device ID: 00894354002304
• NIH Device Record Key: 669c21a8-1bcd-4484-8c54-4acb9c70e7b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyCare Psychiatry
• Version Model Number: MCP2-CAL-US
• Catalog Number: MCP2-CAL-US
• Company DUNS: 144379539
• Company Name: SALADAX BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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	00894354002304 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

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: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [MyCare Psychiatry]

• 00894354002311: Control Kit 2
• 00894354002304: Calibrator Kit 2
• 00894354002236: Clozapine Assay Kit
• 00894354002229: Control Kit 2
• 00894354002212: Calibrator Kit 2