ST AIA-PACK Intact PTH CALIBRATOR SET

GUDID 04560189211421

TOSOH CORPORATION

Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator

• Primary Device ID: 04560189211421
• NIH Device Record Key: acecc7de-ffcf-44ca-86d4-6c687149ed9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK Intact PTH CALIBRATOR SET
• 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: true
• 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: 614-317-1909
• Email: Levent.durukan@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	04560189211421 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-24

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