ST AIA-PACK PRL

GUDID 24560189210831

TOSOH CORPORATION

Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA) Prolactin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 24560189210831
• NIH Device Record Key: 2a25fa93-08fc-45bf-bb0e-97d92437fdc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK PRL
• 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: 650-615-8134
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189210837 [Unit of Use]
GS1	14560189210834 [Primary]
GS1	24560189210831 [Package]; Contains: 14560189210834; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• CFT: Radioimmunoassay, Prolactin (Lactogen)

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: 2024-02-14
• Device Publish Date: 2019-07-25

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• 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