Piccolo AmLyte 13

FDA UDI

Class II (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name: Piccolo AmLyte 13 FDA UDI
Generic Name: Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
Device Name: The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. FDA UDI
Model / Reference: 400-0041 FDA UDI
Description: The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. FDA UDI

Identifiers

Catalog Number: 400-0041 FDA UDI
Primary DI / UDI-DI: EABA40000411 FDA UDI
510(k) Number: K091052 FDA UDI
K934592 FDA UDI
K942782 FDA UDI
K950164 FDA UDI
K992140 FDA UDI
K993211 FDA UDI
FDA Product Code: CIT FDA UDI
CGA FDA UDI
CIG FDA UDI
CJW FDA UDI
CGX FDA UDI
CDN FDA UDI
CKA FDA UDI
CIJ FDA UDI
CJY FDA UDI
JLB FDA UDI
CEM FDA UDI
JGS FDA UDI
DCN 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
862.1035 FDA UDI
862.1225 FDA UDI
862.1770 FDA UDI
862.1030 FDA UDI
862.1070 FDA UDI
862.1145 FDA UDI
862.1210 FDA UDI
862.1600 FDA UDI
862.1665 FDA UDI
866.5270 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Alanine aminotransferase (ALT) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Glucose IVD, reagent Urea IVD, reagent

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

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Cleared under the same submission

K091052 also covers:

Piccolo MetLyte Plus CRP — ABAXIS, INC.

K942782 also covers:

K950164 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 357ce95c-2cbf-4212-8a02-9b7122561618 37 fields · synced May 31, 2026