Piccolo Basic Metabolic Panel Plus

FDA UDI

Class II (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name: Piccolo Basic Metabolic Panel Plus FDA UDI
Generic Name: Total lactate dehydrogenase (LDH) IVD, reagent FDA UDI
Device Name: The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. FDA UDI
Model / Reference: 400-0031 FDA UDI
Description: The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. FDA UDI

Identifiers

Catalog Number: 400-0031 FDA UDI
Primary DI / UDI-DI: EABA40000311 FDA UDI
510(k) Number: K010670 FDA UDI
K040115 FDA UDI
K051108 FDA UDI
K934592 FDA UDI
K942782 FDA UDI
K950164 FDA UDI
K992140 FDA UDI
K993211 FDA UDI
FDA Product Code: CFJ FDA UDI
JGJ FDA UDI
CHJ FDA UDI
JGS FDA UDI
KHS FDA UDI
CEM FDA UDI
CJY FDA UDI
CDN FDA UDI
CGX FDA UDI
CGA FDA UDI
GMDN Term: Total lactate dehydrogenase (LDH) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1440 FDA UDI
862.1495 FDA UDI
862.1170 FDA UDI
862.1665 FDA UDI
862.1160 FDA UDI
862.1600 FDA UDI
862.1145 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 Calcium (Ca2+) IVD, reagent

Piccolo Basic Metabolic Panel Plus 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:

K040115 also covers:

Piccolo MetLac 12 Panel — 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 bd6e9fd5-699e-4231-8ac8-f1e8c359bffb 37 fields · synced Jun 8, 2026