Identity
- Trade Name
- Access PCT FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- C53987 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- C53987 FDA UDI
- Primary DI / UDI-DI
- 15099590736002 FDA UDI
- FDA Product Code
- PTF FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3215 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Access PCT by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay.
- Lumipulse G BRAHMS PCT Immunoreaction Cartridges — FUJIREBIO INC. · Class II
- Elecsys BRAHMS PCT — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- PCT AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- PCT AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- Elecsys BRAHMS PCT — Roche Diagnostics Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 7076f1de-e10e-4819-9dab-2ef5829f535e 34 fields · synced Jun 8, 2026