Cannabinoids DAU Calibrator/Control, Calibrator/Co 0007c

GUDID B0760007C0

5mL/bottle. Concentration: 37.5 ng/mL of 11-nor-Δ9-THC-9-COOH.

LIN-ZHI INTERNATIONAL, INC.

Cannabinoid IVD, control

• Primary Device ID: B0760007C0
• NIH Device Record Key: b58bc448-3282-40ea-83ff-82629f611248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannabinoids DAU Calibrator/Control, Calibrator/Co
• Version Model Number: 0007c
• Catalog Number: 0007c
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0760007C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110239

FDA Product Code

• LAS: Drug Specific Control Materials

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-24
• Device Publish Date: 2016-07-05

On-Brand Devices [Cannabinoids DAU Calibrator/Control, Calibrator/Co]

• B0760076C0: 5mL/bottle. Concentration: 75 ng/mL of 11-nor-Δ9-THC-9-COOH.
• B0760007C0: 5mL/bottle. Concentration: 37.5 ng/mL of 11-nor-Δ9-THC-9-COOH.