AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST

GUDID 04560189284616

TOSOH CORPORATION

Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: 04560189284616
• NIH Device Record Key: 0c7dc128-7d19-4bd9-b927-dd1463d4bd10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST
• Version Model Number: AIA-2000 ST
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 1
• 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: 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 indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and store indoors

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189284616 [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