Access PCT C53987

GUDID 15099590719531

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.

IMMUNOTECH

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590719531
• NIH Device Record Key: f10c67ff-51be-421c-b50a-04195c0b6855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access PCT
• Version Model Number: C53987
• Catalog Number: C53987
• Company DUNS: 270264732
• Company Name: IMMUNOTECH
• 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	15099590719531 [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: 2020-02-10
• Device Publish Date: 2020-01-31

Devices Manufactured by IMMUNOTECH

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• 15099590747312 - BeckmanCoulter: 2021-12-24 CD99-ECD
• 15099590748951 - BeckmanCoulter: 2021-12-24 CD20-SuperNova v605
• 15099590748975 - BeckmanCoulter: 2021-12-24 CD25-SuperNova v605
• 15099590748999 - BeckmanCoulter: 2021-12-24 CD200-SuperNova v786
• 15099590749019 - BeckmanCoulter: 2021-12-24 CD103-SuperNova v786
• 15099590744687 - BeckmanCoulter: 2021-04-06 CD38-SuperNova v428