Identity
- Trade Name
- ABX CRP REA FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 3014042431 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004760 FDA UDI
- 510(k) Number
- K053308 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5270 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
No
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: C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Abx Crp Rea by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry.
- CardioPhase® hsCRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- C-Reactive Protein Gen.3 — Roche Diagnostics Corp. · Class II
- Cardiac CReactive Protein Latex High Sensitive — Roche Diagnostics Corp. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Cardiac CReactive Protein Latex High Sensitive — Roche Diagnostics Corp. · Class II
- Tinaquant CReactive Protein Gen3 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- CReactive Protein Latex) — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K053308 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
- Horiba Abx
Sources (1)
- FDA UDI eea8f5a3-3392-452e-b81c-a932fc4f3da3 33 fields · synced May 30, 2026