RTCII 1st gen. 10-4PX2A-200

GUDID 10694644200505

RTCII 1st GEN COC/OPI2K/AMP/PCP/SVT

AMERICAN BIO MEDICA CORPORATION

Multiple therapeutic drugs/drugs of abuse IVD, calibrator

• Primary Device ID: 10694644200505
• NIH Device Record Key: c88197dd-014b-41dd-aa7e-7be816e98731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTCII 1st gen.
• Version Model Number: 10-4PX2A-200
• Catalog Number: 10-4PX2A-200
• Company DUNS: 966665036
• Company Name: AMERICAN BIO MEDICA 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: 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	10694644200505 [Primary]
GS1	10694644250500 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073078

FDA Product Code

• JXN: Enzyme Immunoassay, Propoxyphene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-11
• Device Publish Date: 2019-10-03

On-Brand Devices [RTCII 1st gen.]

• 10694644200499: RTCII 1st Gen COC/OPI2K/AMP/PCP
• 10694644200505: RTCII 1st GEN COC/OPI2K/AMP/PCP/SVT