Accustrip Saliva Alcohol Test

GUDID 10763924097224

Saliva Alcohol Test Strip

JANT PHARMACAL CORPORATION

Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10763924097224
• NIH Device Record Key: e3b205d3-6bdd-4ebc-a047-270431172204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accustrip Saliva Alcohol Test
• Version Model Number: DS97AC125
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763924097227 [Unit of Use]
GS1	10763924097224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093879

FDA Product Code

• DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

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: 2022-11-28
• Device Publish Date: 2016-09-24

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