Methadone Metabolite 300 DAU Calibrator, Low Calibrator 0192b

GUDID B0760192B0

5mL/bottle. Concentration: 150 ng/mL of EDDP.

LIN-ZHI INTERNATIONAL, INC.

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator

• Primary Device ID: B0760192B0
• NIH Device Record Key: e7726129-d636-4f17-bb28-37483b9f6dd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Methadone Metabolite 300 DAU Calibrator, Low Calibrator
• Version Model Number: 0192b
• Catalog Number: 0192b
• 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	B0760192B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170416

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: 2
• Public Version Date: 2019-10-28
• Device Publish Date: 2018-09-17

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