ST AIA-PACK PROG III

GUDID 24560189213436

TOSOH CORPORATION

Progesterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 24560189213436
• NIH Device Record Key: 31e33819-1439-4931-a084-8dd26a32c025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK PROG III
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 5
• 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: 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189213432 [Unit of Use]
GS1	14560189213439 [Primary]
GS1	24560189213436 [Package]; Contains: 14560189213439; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• JLS: Radioimmunoassay, Progesterone

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: 2019-07-19
• Device Publish Date: 2019-07-11

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• 04562185404920 - Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01: 2026-01-13
• 04562185404937 - 90 Sample Loader: 2026-01-13
• 04562185404944 - 290 Sample Loader: 2026-01-13
• 04562185405255 - TSKgel GR01 HbA1c Column: 2026-01-13
• 14562185405269 - GR01 HbA1c Elution Buffer No. 1: 2026-01-13