PSYCH PANEL LEVEL 1 PSYCH 1 F M ACL

GUDID B800PSYCH1FMACL5

PSYCH PANEL LEVEL 1

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800PSYCH1FMACL5
• NIH Device Record Key: c672a131-971b-4d8d-a9cb-945e33c7cb42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSYCH PANEL LEVEL 1
• Version Model Number: PSYCH 1 F M ACL
• Catalog Number: PSYCH 1 F M ACL
• Company DUNS: 092519016
• Company Name: UTAK LABORATORIES, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800PSYCH1FMACL0 [Primary]
HIBCC	B800PSYCH1FMACL5 [Package]; Contains: B800PSYCH1FMACL0; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• LAS: Drug Specific Control Materials

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: 2024-04-24
• Device Publish Date: 2024-04-16

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• B800CONTROL1V2SSH5 - MIXED CONTROL LEVEL 1 V2: 2026-02-13 MIXED CONTROL LEVEL 1 V2
• B800CONTROL2V2SSH0 - MIXED CONTROL LEVEL 2 V2: 2026-02-13 MIXED CONTROL LEVEL 2 V2
• B800DAUCONT1V2FRX5 - DAU CONTROL LEVEL 1 V2: 2026-02-13 DAU CONTROL LEVEL 1 V2
• B800DAUCONT2V2FRX0 - DAU CONTROL LEVEL 2 V2: 2026-02-13 DAU CONTROL LEVEL 2 V2
• B800EIACAL2V2UFRX5 - EIA CAL LEVEL 2 V2: 2026-02-13 EIA CAL LEVEL 2 V2
• B800EIACALLEVEL1V25 - EIA CAL LEVEL 1 V2: 2026-02-13 EIA CAL LEVEL 1 V2