Rapid ONE 10-XTCS-000

GUDID 10694644800064

Ecstasy Pouched Strip 100/box

AMERICAN BIO MEDICA CORPORATION

Multiple therapeutic drugs/drugs of abuse IVD, calibrator

• Primary Device ID: 10694644800064
• NIH Device Record Key: 44833ce4-28c5-4007-8fe6-a1fa3c806aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid ONE
• Version Model Number: 10-XTCS-000
• Catalog Number: 10-XTCS-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

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10694644800064 [Primary]
GS1	10694644850069 [Unit of Use]

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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