ST AIA-PACK CK-MB

GUDID 14560189210728

TOSOH CORPORATION

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay

• Primary Device ID: 14560189210728
• NIH Device Record Key: f519a249-0ab8-4adf-9bca-a66e683f0b41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST AIA-PACK CK-MB
• 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: 614-317-1909
• Email: Levent.durukan@tosoh.com
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189210721 [Unit of Use]
GS1	14560189210728 [Primary]

FDA Product Code

• JHX: Fluorometric Method, Cpk Or Isoenzymes

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: 2018-03-29
• Device Publish Date: 2016-09-24

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