First Check

GUDID 00643281069122

FIRST CHECK DIAGNOSTIC CORP.

Drug-testing specimen collection kit IVD

• Primary Device ID: 00643281069122
• NIH Device Record Key: a5130898-2f7a-4003-9437-bb45a8308ea3
• Commercial Distribution Discontinuation: 2019-08-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: First Check
• Version Model Number: 12 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: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643281069122 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-02
• Device Publish Date: 2016-06-30

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
• 00643281069122 - First Check: 2019-09-02
• 00643281710055 - First Check(R): 2019-09-02 First Check(R) Home Drug Test, 14 Drug
• 00643881069078 - First Check: 2018-03-29