Identity
- Trade Name
- Elecsys BRAHMS PCT FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 5056888200 FDA UDI
Identifiers
- Catalog Number
- 5056888200 FDA UDI
- Primary DI / UDI-DI
- 04015630939114 FDA UDI
- FDA Product Code
- PMT 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Elecsys BRAHMS PCT by Roche Diagnostics Corp. — 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
- 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
- Atellica IM BRAHMS PCT — Siemens Healthcare Diagnostics · Class II
- PCT AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K160729 also covers:
K173927 also covers:
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 |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI fc2c2986-b944-459e-9ce7-7c1e0a6fa8ce 35 fields · synced May 31, 2026