Piccolo MetLac 12 Panel

FDA UDI

Class I (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name: Piccolo MetLac 12 Panel FDA UDI
Generic Name: Lactate IVD, reagent FDA UDI
Device Name: The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. FDA UDI
Model / Reference: 400-0037 FDA UDI
Description: The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. FDA UDI

Identifiers

Catalog Number: 400-0037 FDA UDI
Primary DI / UDI-DI: EABA40000371 FDA UDI
510(k) Number: K010670 FDA UDI
K022312 FDA UDI
K040115 FDA UDI
K130113 FDA UDI
K934592 FDA UDI
K942782 FDA UDI
K950164 FDA UDI
K992140 FDA UDI
K993211 FDA UDI
FDA Product Code: KHP FDA UDI
JGJ FDA UDI
CEO FDA UDI
CHJ FDA UDI
JGS FDA UDI
KHS FDA UDI
CEM FDA UDI
CJY FDA UDI
CDN FDA UDI
CGX FDA UDI
CJW FDA UDI
CGA FDA UDI
GMDN Term: Lactate IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1450 FDA UDI
862.1495 FDA UDI
862.1580 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
862.1035 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 Inorganic phosphate (PO43-) IVD, reagent Urea IVD, reagent Creatinine IVD, reagent

Piccolo MetLac 12 Panel by Abaxis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K010670 also covers:

K022312 also covers:

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K040115 also covers:

Piccolo Basic Metabolic Panel Plus — 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 I	Pending data

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Manufacturer

Manufacturer: Abaxis, Inc.

Sources (1)

FDA UDI 6c2ced0e-e535-4db2-8ab2-0f9dd0bd3839 37 fields · synced May 31, 2026