Ethyl Alcohol DAU Control, Level 1 Control 0224

GUDID B07602240

5mL/bottle. Concentration: 50 mg/dL of Ethanol.

LIN-ZHI INTERNATIONAL, INC.

Ethanol (ETOH) IVD, calibrator/control

• Primary Device ID: B07602240
• NIH Device Record Key: af05fcb7-d3d5-4c40-b9c0-7e659253921a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethyl Alcohol DAU Control, Level 1 Control
• Version Model Number: 0224
• Catalog Number: 0224
• 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	B07602240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032461

FDA Product Code

• DKC: Alcohol 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

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

• B07605700 - Fentanyl II Enzyme Immunoassay: 2022-08-01 Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• B07605710 - Fentanyl II Enzyme Immunoassay: 2022-08-01 Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07604100 - LZI Tramadol Enzyme Immunoassay: 2022-05-09 Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• B07604110 - LZI Tramadol Enzyme Immunoassay: 2022-05-09 Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• 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.
• B07604140 - LZI Tramadol Intermediate Calibrator: 2022-05-09 5 mL/bottle. Concentration: 225 ng/mL of Tramadol.
• B07604150 - LZI Tramadol High Calibrator: 2022-05-09 5 mL/bottle. Concentration: 400 ng/mL of Tramadol.