AIA-PACK TgAb

GUDID 14560189210490

TOSOH CORPORATION

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 14560189210490
• NIH Device Record Key: 79658eb0-ff03-47b7-99ca-1586a528a6ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIA-PACK TgAb
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 5
• DM Exempt: true
• 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
• 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
• 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
• 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
• 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	04560189210493 [Unit of Use]
GS1	14560189210490 [Primary]

FDA Product Code

• JZO: System, Test, Thyroid Autoantibody

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by TOSOH CORPORATION

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• 04560189210172 - ST AIA-PACK 27.29: 2026-02-10
• 04560189283923 - Hemoglobin A1c Control Set: 2026-01-13
• 04562185400571 - HbA1c Diluting Solution: 2026-01-13
• 04562185403060 - HbA1c Calibrator Set (S): 2026-01-13
• 04562185404920 - Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01: 2026-01-13
• 04562185404937 - 90 Sample Loader: 2026-01-13
• 04562185404944 - 290 Sample Loader: 2026-01-13