DPI 18002999

GUDID 00810042680357

H-Cal 1 5ml

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042680357
• NIH Device Record Key: 83c81f5c-627f-4a68-9446-e9814a9aab67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPI
• Version Model Number: 18002999
• Catalog Number: 18002999
• 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

Customer Support Contacts

• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com

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	00810042680357 [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 [DPI]

• 00810042680364: H-Trol 2 5ml
• 00810042680357: H-Cal 1 5ml
• 00810042680340: H-Trol 1 5ml