Identity
- Trade Name
- Piccolo Kidney Check FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. FDA UDI
- Model / Reference
- 400-0033 FDA UDI
- Description
- The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. FDA UDI
Identifiers
- Catalog Number
- 400-0033 FDA UDI
- Primary DI / UDI-DI
- EABA40000331 FDA UDI
- 510(k) Number
- K942782 FDA UDI
- FDA Product Code
- CDN FDA UDICGX FDA UDI
- GMDN Term
- Urea IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1770 FDA UDI862.1225 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urea IVD, reagentCreatinine IVD, reagent
Piccolo Kidney Check by Abaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatinine IVD, reagent.
- 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
- ClearChem Diagnostics Inc. Creatinine (Jaffe) — CLEARCHEM DIAGNOSTICS INC. · Class II
- CREATININE/ ENDPOINT — STERLING DIAGNOSTICS INC
- Alinity — Abbott Laboratories, Inc. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- CREA — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K942782 also covers:
- Piccolo AmLyte 13 — ABAXIS, INC.
- Piccolo Basic Metabolic Panel — ABAXIS, INC.
- Piccolo Basic Metabolic Panel Plus — ABAXIS, INC.
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC.
- Piccolo Hepatic Function Panel — ABAXIS, INC.
- Piccolo MetLac 12 Panel — ABAXIS, INC.
- Piccolo MetLyte 8 Panel — ABAXIS, INC.
- Piccolo MetLyte Plus CRP — ABAXIS, INC.
- Piccolo Renal Function Panel — ABAXIS, INC.
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
- Abaxis, Inc.
Sources (1)
- FDA UDI 8c84c541-67f3-4d5e-ba1c-98a2255cdb8a 37 fields · synced May 30, 2026