Piccolo Electrolyte Panel

FDA UDI

Class II (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name: Piccolo Electrolyte Panel FDA UDI
Generic Name: Chloride (Cl-) IVD, reagent FDA UDI
Device Name: The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide 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: 400-0022 FDA UDI
Description: The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide 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: 400-0022 FDA UDI
Primary DI / UDI-DI: EABA40000221 FDA UDI
510(k) Number: K010670 FDA UDI
K992140 FDA UDI
K993211 FDA UDI
FDA Product Code: CHJ FDA UDI
JGS FDA UDI
KHS FDA UDI
CEM FDA UDI
GMDN Term: Chloride (Cl-) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1170 FDA UDI
862.1665 FDA UDI
862.1160 FDA UDI
862.1600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Potassium (K+) IVD, reagent Chloride (Cl-) IVD, reagent Bicarbonate (HCO3-) IVD, reagent Sodium (Na+) IVD, control

Piccolo Electrolyte Panel by Abaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K010670 also covers:

K992140 also covers:

K993211 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: Abaxis, Inc.

Sources (1)

FDA UDI e6e1353c-eea3-47be-88ae-42a0c5a5fb58 37 fields · synced May 31, 2026