BioSign® Mono card BSP-402WB-35-01

GUDID 10743816000921

BioSign® Mono card; 35 Test kit; CE

PRINCETON BIOMEDITECH CORPORATION

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816000921
• NIH Device Record Key: bced8dca-0afb-439c-a98b-204e40889d89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSign® Mono card
• Version Model Number: BSP-402WB-35-01
• Catalog Number: BSP-402WB-35-01
• 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: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• 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	10743816000921 [Primary]

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

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: 2022-06-10
• Device Publish Date: 2016-09-23

On-Brand Devices [BioSign® Mono card]

• 10743816000938: BioSign® Mono card; 10 Test kit; CE
• 10743816000921: BioSign® Mono card; 35 Test kit; CE