AccuSign® MTD card DOA-208-10-02

GUDID 10743816000198

AccuSign® MTD card; 10 Test kit; CE

PRINCETON BIOMEDITECH CORPORATION

Methadone IVD, kit, rapid ICT, clinical Methadone IVD, kit, rapid ICT, clinical Methadone IVD, kit, rapid ICT, clinical Methadone IVD, kit, rapid ICT, clinical Methadone IVD, kit, rapid ICT, clinical Methadone IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816000198
• NIH Device Record Key: cb97752a-16a0-48fc-ba19-b99a86ee8a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuSign® MTD card
• Version Model Number: DOA-208-10-02
• Catalog Number: DOA-208-10-02
• Company DUNS: 362917692
• Company Name: PRINCETON BIOMEDITECH CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 732-274-1000
• Email: info@pbmc.com
• Phone: 732-274-1000
• Email: info@pbmc.com
• Phone: 732-274-1000
• Email: info@pbmc.com
• Phone: 732-274-1000
• Email: info@pbmc.com
• Phone: 732-274-1000
• Email: info@pbmc.com
• Phone: 732-274-1000
• Email: info@pbmc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816000198 [Primary]

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-23

On-Brand Devices [AccuSign® MTD card]

• 10743816000198: AccuSign® MTD card; 10 Test kit; CE
• 10743816000181: AccuSign® MTD card; 35 Test kit; CE