Premier PQ-22-01

GUDID 00810042683952

22 Panel Low Positive 2x5mL

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042683952
• NIH Device Record Key: be6a86e3-be52-4252-aa6a-661edab8e407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier
• Version Model Number: PQ-22-01
• Catalog Number: PQ-22-01
• Company DUNS: 028007698
• Company Name: BIOCHEMICAL DIAGNOSTICS 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810042683952 [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: 2024-06-06
• Device Publish Date: 2024-05-29

On-Brand Devices [Premier]

• 00810042683969: 22 Panel High Positive 2x5mL
• 00810042683952: 22 Panel Low Positive 2x5mL