Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300

GUDID 04562185404814

TOSOH CORPORATION

Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD

• Primary Device ID: 04562185404814
• NIH Device Record Key: e354f563-4089-4ae2-afb4-c4d4735d4e27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300
• Version Model Number: AIA-CL300
• 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 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
• 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	04562185404814 [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

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