Identity
- Trade Name
- CREA FDA UDI
- Generic Name
- Creatinine IVD, reagent FDA UDI
- Device Name
- The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic device intended for the quantitative determination of Creatinine in serum, plasma or urine FDA UDI
- Model / Reference
- CR2804 FDA UDI
- Description
- The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic device intended for the quantitative determination of Creatinine in serum, plasma or urine FDA UDI
Identifiers
- Catalog Number
- CR2804 FDA UDI
- Primary DI / UDI-DI
- 05055273201888 FDA UDI
- 510(k) Number
- K973993 FDA UDI
- FDA Product Code
- CGX FDA UDI
- GMDN Term
- Creatinine IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1225 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: Creatinine IVD, reagent
Crea by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatinine IVD, reagent.
- Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
- Electrode for ABL analyzers — Radiometer Medical ApS · Class II
- Electrode for ABL analyzers — Radiometer Medical ApS · Class II
- Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480 — TECO DIAGNOSTICS · Class II
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- ClearChem Diagnostics Inc. Creatinine (Jaffe) — CLEARCHEM DIAGNOSTICS INC. · Class II
- CREATININE/ ENDPOINT — STERLING DIAGNOSTICS INC
- Alinity — Abbott Laboratories, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI aa4e63c2-0702-4569-9673-10a8b0ada673 37 fields · synced May 30, 2026