LZI Tramadol Low Calibrator 0412

GUDID B07604120

5 mL/bottle. Concentration: 50 ng/mL of Tramadol.

LIN-ZHI INTERNATIONAL, INC.

Tramadol IVD, calibrator

• Primary Device ID: B07604120
• NIH Device Record Key: 178a4619-845c-41d3-b484-580706193a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LZI Tramadol Low Calibrator
• Version Model Number: 0412
• Catalog Number: 0412
• Company DUNS: 840839190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07604120 [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: 2022-05-09
• Device Publish Date: 2022-05-01

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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• B07604120 - LZI Tramadol Low Calibrator: 2022-05-09 5 mL/bottle. Concentration: 50 ng/mL of Tramadol.
• B07604130 - LZI Tramadol Cutoff Calibrator: 2022-05-09 5 mL/bottle. Concentration: 100 ng/mL of Tramadol.
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• B07604150 - LZI Tramadol High Calibrator: 2022-05-09 5 mL/bottle. Concentration: 400 ng/mL of Tramadol.