ST AIA-PACK CA 19-9

GUDID 14560189210209

TOSOH CORPORATION

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 14560189210209
• NIH Device Record Key: 15ca9fd1-6cef-47a1-830d-a9123bfe896e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK CA 19-9
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 614-317-1909
• Email: Levent.durukan@tosoh.com
• Phone: 614-317-1909
• Email: Levent.durukan@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189210202 [Unit of Use]
GS1	14560189210209 [Primary]

FDA Product Code

• NIG: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

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: 2019-01-08
• Device Publish Date: 2016-09-24

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