CL AIA-PACK Progesterone SAMPLE DILUTING REAGENT

GUDID 24562185399688

TOSOH CORPORATION

Progesterone IVD, reagent

• Primary Device ID: 24562185399688
• NIH Device Record Key: 5d45793e-99b4-4c60-87a4-629f7a39fd97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CL AIA-PACK Progesterone SAMPLE DILUTING REAGENT
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 3
• 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: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04562185399684 [Unit of Use]
GS1	14562185399681 [Primary]
GS1	24562185399688 [Package]; Contains: 14562185399681; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• GIF: Diluent, Blood Cell

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: 2025-09-09
• Device Publish Date: 2025-09-01

Devices Manufactured by TOSOH CORPORATION

• 24560189216321 - CL AIA-PACK Prolactin II TEST CUP: 2025-09-09
• 24560189216338 - CL AIA-PACK Prolactin II ADJUSTER SET: 2025-09-09
• 24560189216628 - CL AIA-PACK hs-E2 TEST CUP: 2025-09-09
• 24560189216635 - CL AIA-PACK hs-E2 ADJUSTER SET: 2025-09-09
• 24562185395390 - CL AIA-PACK SAMPLE DILUTING REAGENT A: 2025-09-09
• 24562185395444 - CL AIA-PACK T3 TEST CUP: 2025-09-09
• 24562185395451 - CL AIA-PACK T3 ADJUSTER SET: 2025-09-09
• 24562185399657 - CL AIA-PACK SAMPLE DILUTING REAGENT D: 2025-09-09