Benzodiazepine DAU Calibrator/Control, Calibrator 0134

GUDID B07601340

5mL/bottle. Concentration: 300 ng/mL of Oxazepam.

LIN-ZHI INTERNATIONAL, INC.

Benzodiazepine group IVD, control Benzodiazepine group IVD, control

• Primary Device ID: B07601340
• NIH Device Record Key: 03735704-cc35-4356-ba4b-553b1ab8659c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Benzodiazepine DAU Calibrator/Control, Calibrator
• Version Model Number: 0134
• Catalog Number: 0134
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07601340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032365

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 [Benzodiazepine DAU Calibrator/Control, Calibrator ]

• B07601340: 5mL/bottle. Concentration: 300 ng/mL of Oxazepam.
• B07601330: 5mL/bottle. Concentration: 200 ng/mL of Oxazepam.
• B07601320: 5mL/bottle. Concentration: 100 ng/mL of Oxazepam.