Piccolo MetLyte Plus CRP

FDA UDI

Class II (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name: Piccolo MetLyte Plus CRP FDA UDI
Generic Name: C-reactive protein (CRP) IVD, reagent FDA UDI
Device Name: The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide 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: 400-0034 FDA UDI
Description: The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide 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: 400-0034 FDA UDI
Primary DI / UDI-DI: EABA40000341 FDA UDI
510(k) Number: K010670 FDA UDI
K091052 FDA UDI
K934592 FDA UDI
K942782 FDA UDI
K992140 FDA UDI
K993211 FDA UDI
FDA Product Code: DCN FDA UDI
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: C-reactive protein (CRP) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5270 FDA UDI
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

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: Glucose IVD, reagent Urea IVD, reagent Creatinine IVD, reagent C-reactive protein (CRP) IVD, reagent

Piccolo MetLyte Plus CRP 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:

K091052 also covers:

Piccolo AmLyte 13 — ABAXIS, INC.

K942782 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 3015c06d-d980-4781-a503-a1f2450ea422 37 fields · synced May 30, 2026