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Piccolo MetLyte 8 Panel

FDA UDI

Class II (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name
Piccolo MetLyte 8 Panel FDA UDI
Generic Name
Chloride (Cl-) IVD, reagent FDA UDI
Device Name
The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide 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
400-0023 FDA UDI
Description
The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide 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
400-0023 FDA UDI
Primary DI / UDI-DI
EABA40000231 FDA UDI
510(k) Number
K010670 FDA UDI
K934592 FDA UDI
K942782 FDA UDI
K992140 FDA UDI
K993211 FDA UDI
FDA Product Code
CHJ FDA UDI
JGS FDA UDI
KHS FDA UDI
CEM FDA UDI
JLB FDA UDI
CDN FDA UDI
CGX FDA UDI
CGA 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
862.1210 FDA UDI
862.1770 FDA UDI
862.1225 FDA UDI
862.1345 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: Glucose IVD, reagentUrea IVD, reagentCreatinine IVD, reagentTotal creatine kinase (CK) IVD, reagent

Piccolo MetLyte 8 Panel by Abaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sodium (Na+) IVD, control.

Cleared under the same submission

K010670 also covers:

K934592 also covers:

K942782 also covers:

K992140 also covers:

K993211 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abaxis, Inc.

Sources (1)

  • FDA UDI 11474676-58e3-4809-ad65-a3f4dabbffc5 37 fields · synced May 30, 2026