Express Check 18001264

GUDID 00810042680173

Express Check Positive 20mL

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042680173
• NIH Device Record Key: a98dbafd-001b-47b3-963c-ebc90e21b020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Express Check
• Version Model Number: 18001264
• Catalog Number: 18001264
• Company DUNS: 028007698
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810042680173 [Primary]

FDA Product Code

• DIF: Drug Mixture 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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [Express Check]

• 00810042680173: Express Check Positive 20mL
• 00810042680142: Express Check Negative, 20mL