Cellmek

GUDID 15099590750312

Cellmek SPS

Beckman Coulter, Inc.

Specimen processing instrument IVD

• Primary Device ID: 15099590750312
• NIH Device Record Key: 780bb255-f87e-46a2-b6fa-0419f2159209
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellmek
• Version Model Number: C44603
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	15099590750312 [Primary]

FDA Product Code

• PER: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-10
• Device Publish Date: 2025-09-02

Devices Manufactured by Beckman Coulter, Inc.

• 15099590750312 - Cellmek: 2025-09-10Cellmek SPS
• 15099590750312 - Cellmek: 2025-09-10 Cellmek SPS
• 15099590754013 - DxFLEX: 2025-09-10 DxFLEX Flow Cytometer
• 15099590701673 - Access Hybritech PSA: 2025-06-09 The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of to
• 15099590701680 - Access Hybritech free PSA: 2025-06-09 The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination
• 15099590763626 - Access Syphilis Reagent: 2025-05-15 The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibo
• 15099590763633 - Access Syphilis Calibrators: 2025-05-15 The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. B
• 15099590763640 - Access Syphilis QC: 2025-05-15 The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for
• 05099590798218 - DxH: 2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid