Auto-Prep Unit for AIA-CL1200

GUDID 04562185400601

TOSOH CORPORATION

Chemiluminescent immunoassay analyser IVD

• Primary Device ID: 04562185400601
• NIH Device Record Key: c166fd7e-5443-4674-9179-6df4f62c8ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto-Prep Unit for AIA-CL1200
• 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: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• Email: dave.wurtz@tosoh.com
• Phone: 650-636-8228
• 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
• 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
• 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	04562185400601 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2023-06-22
• Device Publish Date: 2023-06-14

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