Access CK-MB 386371

GUDID 15099590232368

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and

Beckman Coulter, Inc.

Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent

• Primary Device ID: 15099590232368
• NIH Device Record Key: 80bd0948-4b72-4fbb-9d89-f2671ab2d010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access CK-MB
• Version Model Number: 386371
• Catalog Number: 386371
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590232368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030012

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: 2018-04-09
• Device Publish Date: 2016-09-09

On-Brand Devices [Access CK-MB]

• 15099590232368: The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantita
• 15099590781521: The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantita