Identity
- Trade Name
- CRP CAL FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, calibrator FDA UDI
- Device Name
- The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems. FDA UDI
- Model / Reference
- CP2179 FDA UDI
- Description
- The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems. FDA UDI
Identifiers
- Catalog Number
- CP2179 FDA UDI
- Primary DI / UDI-DI
- 05055273201659 FDA UDI
- 510(k) Number
- K022682 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
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
No
FDA UDI
Category: C-reactive protein (CRP) IVD, calibrator
Crp Cal by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, calibrator.
- ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators — Siemens Healthcare Diagnostics · Class II
- CRP Ultra WR Calibrator — Sekisui Diagnostics, LLC · Class II
- ABX Pentra CRP HS Cal — Horiba Abx · Class II
- POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L) — POINTE SCIENTIFIC, INC. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L) — POINTE SCIENTIFIC, INC. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- K-ASSAY® CRP (3) Calibrator E — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
Cleared under the same submission
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI ea4888c6-a8b9-452a-bd38-3f02f97dbb1e 37 fields · synced Jun 1, 2026