ST AIA-PACK 27.29

GUDID 04560189210172

TOSOH CORPORATION

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04560189210172
• NIH Device Record Key: 4e30b689-837d-42ec-a147-8fa3a3067876
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK 27.29
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 5
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189210172 [Unit of Use]
GS1	14560189212081 [Primary]

FDA Product Code

• MOI: System, Test, Immunological, Antigen, Tumor

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: 2026-02-10
• Device Publish Date: 2026-02-02

On-Brand Devices [ST AIA-PACK 27.29]

• 14560189210179: N/A
• 04560189210172: N/A