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Piccolo General Chemistry 13

FDA UDI

Class II (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name
Piccolo General Chemistry 13 FDA UDI
Generic Name
Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
Device Name
The Piccolo® General Chemistry 13 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), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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
400-0029 FDA UDI
Description
The Piccolo® General Chemistry 13 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), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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
400-0029 FDA UDI
Primary DI / UDI-DI
EABA40000291 FDA UDI
FDA Product Code
CIT FDA UDI
CGA FDA UDI
CIG FDA UDI
CEK FDA UDI
KNK FDA UDI
CJW FDA UDI
CGX FDA UDI
CDN FDA UDI
CKA FDA UDI
CKF FDA UDI
CIJ FDA UDI
CJY FDA UDI
JQB FDA UDI
GMDN Term
Total aspartate aminotransferase (AST) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1100 FDA UDI
862.1345 FDA UDI
862.1110 FDA UDI
862.1635 FDA UDI
862.1775 FDA UDI
862.1035 FDA UDI
862.1225 FDA UDI
862.1770 FDA UDI
862.1030 FDA UDI
862.1050 FDA UDI
862.1070 FDA UDI
862.1145 FDA UDI
862.1360 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: Uric acid IVD, reagentAlanine aminotransferase (ALT) IVD, reagentTotal aspartate aminotransferase (AST) IVD, reagentGamma-glutamyltransferase (GGT) IVD, reagent

Piccolo General Chemistry 13 by Abaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total amylase 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 6974d4f7-b8df-444f-b3ac-e41b4edb5ded 36 fields · synced May 30, 2026