Who else makes this device?

Name: Piccolo MetLac 12 Panel
Brand: Piccolo MetLac 12 Panel

Clinical Chemistry › Test SystemsAcid, Lactic, Enzymatic Method

Piccolo MetLac 12 Panel

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,…

Registry build 21.09.26

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.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shandong (1), Hunan (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code KHP
Manufacturer	City	Province	Registered as	Device types
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
AVE Science & Technology Co., Ltd.	Changsha	Hunan	Manufacturer	22
Eaglenos Sciences, Inc.	Nanjing	Jiangsu	Manufacturer	4

Record

Regulatory record for Piccolo MetLac 12 Panel
Listed by	Abaxis, Inc., United States
FDA product code	KHP
Device type	Acid, Lactic, Enzymatic Method
Device class	Class 1
Regulation	21 CFR 862.1450
Establishment	Manufacturer
510(k)	K010670
Record published	2016-09-23
Record revised	2025-08-18 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment temperature 36 to 46 °F; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Piccolo MetLac 12 Panel
Catalogue number	Size	Per pack	Status
400-0037		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
StatSensor/StatStrip	Nova Biomedical Corporation	5
Stat Profile	Nova Biomedical Corporation	5
Lactate Gen.2	Roche Diagnostics Gmbh	4
Lactate Plus	Nova Biomedical Corporation	4
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	3
i-STAT	Abbott Point OF Care Inc.	3
Alinity	Abbott Medical	2
Fora	Fora Care Inc.	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2
LA Cartridge	LifeHealth, LLC	2
L-Lactate (LAC)	Randox Laboratories Limited	2
ABX Pentra Lactic Acid	Horiba ABX SAS	1

Showing 12 of 43. All products under Acid, Lactic, Enzymatic Method

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130113	2013-03-11

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.