Rapid ONE 10-OPIS-001

GUDID 10694644800033

Opi 2K pouched strips 100/box

AMERICAN BIO MEDICA CORPORATION

Opiate/opiate metabolite IVD, calibrator

• Primary Device ID: 10694644800033
• NIH Device Record Key: f123b092-342f-4fe8-8553-38d16f9061b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid ONE
• Version Model Number: 10-OPIS-001
• Catalog Number: 10-OPIS-001
• Company DUNS: 966665036
• Company Name: AMERICAN BIO MEDICA CORPORATION
• Device Count: 100
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 518-758-8158
• Email: customerservice@abmc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10694644800033 [Primary]
GS1	10694644850038 [Unit of Use]

FDA Product Code

• DKG: Plate, Cellulose, Tlc

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: 2020-01-13
• Device Publish Date: 2016-09-23

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