LAMOTRIGINE PLUS LEVEL 2 LAMO+ 2 V3 S UCH

GUDID B800LAMO2V3SUCH5

LAMOTRIGINE PLUS LEVEL 2

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control

• Primary Device ID: B800LAMO2V3SUCH5
• NIH Device Record Key: a65862eb-8770-4ae5-84cf-64f736d8f00f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LAMOTRIGINE PLUS LEVEL 2
• Version Model Number: LAMO+ 2 V3 S UCH
• Catalog Number: LAMO+ 2 V3 S UCH
• 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: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 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	B800LAMO2V3SUCH0 [Primary]
HIBCC	B800LAMO2V3SUCH5 [Package]; Contains: B800LAMO2V3SUCH0; Package: BOX [36 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: 2024-05-10
• Device Publish Date: 2024-05-02

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• B800DAUPOSFV3UVHS5 - DAU POSITIVE V3: 2024-10-17 DAU POSITIVE V3
• B800CDFUL12GALJNC5 - CERTIFIED DRUG FREE URINE: 2024-10-11 CERTIFIED DRUG FREE URINE
• B800VOLHIGHSULH5 - VOLATILES HIGH: 2024-10-10 VOLATILES HIGH
• B800QCA1OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 1: 2024-10-09 DRUGS OF ABUSE QC A LEVEL 1
• B800QCA2OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 2: 2024-10-09 DRUGS OF ABUSE QC A LEVEL 2
• B800QCA3OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 3: 2024-10-09 DRUGS OF ABUSE QC A LEVEL 3
• B80090000UFLTI5 - NICOTINE PLUS LEVEL 1: 2024-10-08 NICOTINE PLUS LEVEL 1