Rapid ONE 10-THCS-000

GUDID 10694644800057

THC pouched strip 100/box

AMERICAN BIO MEDICA CORPORATION

Multiple therapeutic drugs/drugs of abuse IVD, calibrator

• Primary Device ID: 10694644800057
• NIH Device Record Key: 8b00903e-fd1e-4f4f-a8cd-16ea60d3423c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid ONE
• Version Model Number: 10-THCS-000
• Catalog Number: 10-THCS-000
• 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	10694644800057 [Primary]
GS1	10694644850052 [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

On-Brand Devices [Rapid ONE]

• 10694644800064: Ecstasy Pouched Strip 100/box
• 10694644800057: THC pouched strip 100/box
• 10694644800040: Cocaine pouched strips 100/box
• 10694644800033: Opi 2K pouched strips 100/box
• 10694644800026: Opi 300 pouched strip 100/box
• 10694644800019: Methamphetamine pouch str 100
• 10694644800002: Amp pouched strip 100/box
• 10694644100416: THCsingle50/cs 90-grimex only
• 10694644100409: COCsingle/50cs 90-grimex only