Cannabinoids DAU Calibrator, Calibrator 0077c

GUDID B0760077C0

5mL/bottle. Concentration: 100 ng/mL of 11-nor-Δ9-THC-9-COOH.

LIN-ZHI INTERNATIONAL, INC.

Cannabinoid IVD, calibrator

• Primary Device ID: B0760077C0
• NIH Device Record Key: 0902dbd7-4a97-49e2-bf4a-d43f9f9ab725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannabinoids DAU Calibrator, Calibrator
• Version Model Number: 0077c
• Catalog Number: 0077c
• 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	B0760077C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110239

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: 4
• Public Version Date: 2018-08-24
• Device Publish Date: 2016-07-05

On-Brand Devices [Cannabinoids DAU Calibrator, Calibrator]

• B0760079C0: 5mL/bottle. Concentration: 200 ng/mL of 11-nor-Δ9-THC-9-COOH.
• B0760078C0: 5mL/bottle. Concentration: 150 ng/mL of 11-nor-Δ9-THC-9-COOH.
• B0760077C0: 5mL/bottle. Concentration: 100 ng/mL of 11-nor-Δ9-THC-9-COOH.
• B0760075C0: 5mL/bottle. Concentration: 50 ng/mL of 11-nor-Δ9-THC-9-COOH.
• B0760073C0: 5mL/bottle. Concentration: 25 ng/mL of 11-nor-Δ9-THC-9-COOH.
• B0760072C0: 5mL/bottle. Concentration: 12.5 ng/mL of 11-nor-Δ9-THC-9-COOH.