Access PCT C53987

GUDID 15099590736002

The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.

Beckman Coulter, Inc.

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590736002
• NIH Device Record Key: 7076f1de-e10e-4819-9dab-2ef5829f535e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access PCT
• Version Model Number: C53987
• Catalog Number: C53987
• 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	15099590736002 [Primary]

FDA Product Code

• PTF: Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

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: 2023-05-15
• Device Publish Date: 2023-05-05

Devices Manufactured by Beckman Coulter, Inc.

• 15099590762889 - Stem-Kit Reagents: 2024-11-04 Stem-Kit Reagents
• 15099590762896 - StemTrol Control Cells: 2024-11-04 StemTrol Control Cells
• 15099590732103 - DxI 9000 Access Immunoassay Analyzer: 2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali
• 15099590575243 - Access hLH: 2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing
• 15099590760823 - Access NT-proBNP: 2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term
• 15099590760830 - ACCESS NT-proBNP CALIBRATORS: 2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
• 15099590772840 - Access Ferritin: 2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti
• 15099590745158 - ACCESS HIV Ag/Ab combo: 2024-03-25 The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vi