19tray Sorter

GUDID 04560189284012

TOSOH CORPORATION

Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: 04560189284012
• NIH Device Record Key: 6ad814df-3183-4664-85bc-06285a0f9578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 19tray Sorter
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@tosoh.com
• Phone: 650-636-8228
• Email: Ken.Hood@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
• Phone: 650-615-8134
• Email: Dave.Wurtz@Tosoh.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoor

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189284012 [Primary]

FDA Product Code

• KHO: Fluorometer, For Clinical Use

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: 2022-09-16
• Device Publish Date: 2019-09-02

Devices Manufactured by TOSOH CORPORATION

• 14560189212234 - AIA-PACK AFP Calibration Verification Test Set: 2024-04-01
• 14560189212241 - AIA-PACK CEA Calibration Verification Test Set: 2024-04-01
• 14560189212258 - AIA-PACK FER Calibration Verification Test Set: 2024-04-01
• 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