ANTIPSYCHOTICS URINE PLUS V3 ANTIPSYCH+ V3 U F ODX

GUDID B800ANTIPSYCHV3UFODX5

ANTIPSYCHOTICS URINE PLUS V3

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800ANTIPSYCHV3UFODX5
• NIH Device Record Key: 78975b7c-f955-4cc5-96ee-a845c31d194c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTIPSYCHOTICS URINE PLUS V3
• Version Model Number: ANTIPSYCH+ V3 U F ODX
• Catalog Number: ANTIPSYCH+ V3 U F ODX
• 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: true
• 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: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800ANTIPSYCHV3UFODX0 [Primary]
HIBCC	B800ANTIPSYCHV3UFODX5 [Package]; Contains: B800ANTIPSYCHV3UFODX0; Package: [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: 2025-03-13
• Device Publish Date: 2025-03-05

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• B800COT25SWDL5 - COTININE PLUS 25 NG/ML: 2025-05-21 COTININE PLUS 25 NG/ML
• B800COT5SWDL5 - COTININE PLUS 5 NG/ML: 2025-05-21 COTININE PLUS 5 NG/ML
• B800CREAALDD5 - CREATININE PLUS: 2025-05-21 CREATININE PLUS
• B800GABA1V3SMXUFPG5 - GABAPENTIN LEVEL 1: 2025-05-16 GABAPENTIN LEVEL 1
• B800GABA2V2SMXUFPG5 - GABAPENTIN LEVEL 2: 2025-05-16 GABAPENTIN LEVEL 2