First Check(R)

GUDID 00643281710055

First Check(R) Home Drug Test, 14 Drug

FIRST CHECK DIAGNOSTIC CORP.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00643281710055
• NIH Device Record Key: da205c1e-980f-4757-9b2e-d787eb46500c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Check(R)
• Version Model Number: 14 Drug Test
• Company DUNS: 945331317
• Company Name: FIRST CHECK DIAGNOSTIC CORP.
• 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: true
• 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: true

Customer Support Contacts

• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com
• Phone: 1-888-788-5716
• Email: info@firstcheckfamily.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643281710055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122633

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-02
• Device Publish Date: 2018-04-11

Devices Manufactured by FIRST CHECK DIAGNOSTIC CORP.

• 00643281801128 - First Check: 2019-09-16
• 00643281069078 - First Check: 2019-09-02
• 00643281061553 - First Check: 2019-09-02 First Check Home Drug Test One Drug Marijuana
• 00643281067555 - First Check: 2019-09-02
• 00643281069047 - First Check: 2019-09-02
• 00643281069122 - First Check: 2019-09-02
• 00643281710055 - First Check(R): 2019-09-02First Check(R) Home Drug Test, 14 Drug
• 00643281710055 - First Check(R): 2019-09-02 First Check(R) Home Drug Test, 14 Drug
• 00643881069078 - First Check: 2018-03-29