Access CK-MB Calibrators 386372

GUDID 15099590232412

The Access CK-MB Calibrators are intended to calibrate the Access CK-MB assay for the quantitative determination of CK-MB levels in human serum and pl

Beckman Coulter, Inc.

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

• Primary Device ID: 15099590232412
• NIH Device Record Key: 01bc4751-3560-4c5e-80e9-8adeaf608900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access CK-MB Calibrators
• Version Model Number: 386372
• Catalog Number: 386372
• 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	15099590232412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030012

FDA Product Code

• JIS: Calibrator, Primary

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

Devices Manufactured by Beckman Coulter, Inc.

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• 05099590798980 - MicroScan: 2025-12-16 MicroScan Neg Combo 104
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• 05099590799000 - MicroScan: 2025-12-16 MicroScan Neg Combo 106
• 05099590799017 - MicroScan: 2025-12-16 MicroScan Pos Combo 50
• 05099590799024 - MicroScan: 2025-12-16 MicroScan Pos MIC 41
• 15099590799243 - MicroScan: 2025-12-16 MicroScan LabPro V5.03 Panel Update 11 (US), Electronic
• 15099590799250 - MicroScan: 2025-12-16 MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US)