PATHFAST CK-MB-II

GUDID 04987595301339

LSI MEDIENCE CORPORATION

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

• Primary Device ID: 04987595301339
• NIH Device Record Key: be444783-75e7-4a9f-bc18-ab7123395721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATHFAST CK-MB-II
• Version Model Number: N/A
• Company DUNS: 691093090
• Company Name: LSI MEDIENCE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987595301339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081360

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by LSI MEDIENCE CORPORATION

• 04987595300646 - PATHFAST: 2023-06-20
• 04987595301131 - PATHFAST cTnI-II: 2018-07-06
• 04987595301230 - PATHFAST Myo-II: 2018-07-06
• 04987595301339 - PATHFAST CK-MB-II: 2018-07-06
• 04987595301339 - PATHFAST CK-MB-II: 2018-07-06
• 04987595301636 - PATHFAST NTproBNP: 2018-07-06
• 04987595301742 - PATHFAST hsCRP: 2018-07-06
• 04987595301537 - PATHFAST D-Dimer: 2018-03-29