Norbuprenorphine DAU Calibrator, Cutoff Calibrator A68827

GUDID 00869335000242

5mL/bottle. Concentration: 10 ng/mL of Norbuprenorphine.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, calibrator

• Primary Device ID: 00869335000242
• NIH Device Record Key: d80cc293-edc1-4a36-bd26-9a0246fe2271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norbuprenorphine DAU Calibrator, Cutoff Calibrator
• Version Model Number: A68827
• Catalog Number: A68827
• Company DUNS: 840839190
• Company Name: LIN-ZHI INTERNATIONAL, 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869335000242 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-07-05

On-Brand Devices [Norbuprenorphine DAU Calibrator, Cutoff Calibrator]

• 00869335000242: 5mL/bottle. Concentration: 10 ng/mL of Norbuprenorphine.
• B07602750: 5mL/bottle. Concentration: 10 ng/mL of Norbuprenorphine.