Oral Fluid Negative Calibrator S0001

GUDID B076S00010

5 mL/bottle. Concentration: negative (drug-free) saliva buffer.

LIN-ZHI INTERNATIONAL, INC.

Multiple drugs of abuse IVD, calibrator

• Primary Device ID: B076S00010
• NIH Device Record Key: 070b152d-ca87-4256-bc72-50f203136cbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral Fluid Negative Calibrator
• Version Model Number: S0001
• Catalog Number: S0001
• 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	B076S00010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131652

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: 2016-07-19

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