Methadone Metabolite 100 Qualitative Calibrator Set 08735590190

GUDID 00850624008186

EDDP 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL).

LIN-ZHI INTERNATIONAL, INC.

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

• Primary Device ID: 00850624008186
• NIH Device Record Key: 4d169c5c-6f23-408f-bba6-f671416a0ff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Methadone Metabolite 100 Qualitative Calibrator Set
• Version Model Number: 08735590190
• Catalog Number: 08735590190
• 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	00850624008186 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-16

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