ST AIA-PACK PA

GUDID 14560189212104

TOSOH CORPORATION

Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 14560189212104
• NIH Device Record Key: 39ac504a-56f1-4ebe-ac90-4e2ab9707fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK PA
• 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: 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: 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: 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
• 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	04560189212107 [Unit of Use]
GS1	14560189212104 [Primary]

FDA Product Code

• LTJ: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

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: 2020-02-06
• Device Publish Date: 2014-09-24

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• 14560189212272 - AIA-PACK PAP CALIBRATION VERIFICATION TEST SET: 2024-04-01
• 14560189212296 - AIA-PACK bHCG Calibration Verification Test Set: 2024-04-01
• 14560189212807 - AIA-PACK Homocysteine Control Set: 2024-04-01
• 14560189211190 - AIA-PACK FT3 Calibrator Set: 2024-02-14
• 14560189211213 - AIA-PACK TT3 SAMPLE DILUTING SOLUTION: 2024-02-14