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Piccolo General Chemistry 6

FDA UDI

Class I (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name
Piccolo General Chemistry 6 FDA UDI
Generic Name
Gamma-glutamyltransferase (GGT) IVD, reagent FDA UDI
Device Name
The Piccolo® General Chemistry 6 , 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 alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, 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
400-0006 FDA UDI
Description
The Piccolo® General Chemistry 6 , 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 alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, 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
400-0006 FDA UDI
Primary DI / UDI-DI
EABA40000061 FDA UDI
FDA Product Code
JQB FDA UDI
CKA FDA UDI
CDN FDA UDI
CGX FDA UDI
CGA FDA UDI
CIT FDA UDI
GMDN Term
Gamma-glutamyltransferase (GGT) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1360 FDA UDI
862.1030 FDA UDI
862.1770 FDA UDI
862.1225 FDA UDI
862.1345 FDA UDI
862.1100 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: Alanine aminotransferase (ALT) IVD, reagentTotal aspartate aminotransferase (AST) IVD, reagentGamma-glutamyltransferase (GGT) IVD, reagentGlucose IVD, reagent

Piccolo General Chemistry 6 by Abaxis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Creatinine IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abaxis, Inc.

Sources (1)

  • FDA UDI bf582224-a8e2-4998-a236-e2df1f7b648b 36 fields · synced May 30, 2026