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ABAXIS, INC.

United States·US-MF-000021651

Last updated September 17, 2026

Information

Country: United States
Address: 3240, Whipple Road, Union City, United States
Website: www.abaxis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 800 822 2947
PRRC Contact: Jigarkumar Modh
EUDAMED SRN: US-MF-000021651
FDA FEI Number: 2939693
DUNS Number: 555503770

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
Piccolo Hepatic Function Panel	400-0026	FDA UDI	Class II	Active
Piccolo Comprehensive Metabolic Panel	400-0028	FDA UDI	Class II	Active
Piccolo Renal Function Panel	400-0027	FDA UDI	Class I	Active
Piccolo Kidney Check	400-0033	FDA UDI	Class II	Active
Piccolo MetLyte 8 Panel	400-0023	FDA UDI	Class II	Active
Piccolo Basic Metabolic Panel Plus	400-0031	FDA UDI	Class II	Active
Piccolo Xpress Military Deployment Kit	1100-1511	FDA UDI	Class I	Active
Piccolo Xpress	1100-0000	FDA UDI	Class I	Active
Piccolo Lipid Panel Plus	400-0030	FDA UDI	Class I	Active
Piccolo General Chemistry 6	400-0006	FDA UDI	Class I	Active
Piccolo General Chemistry 13	400-0029	FDA UDI	Class II	Active
Piccolo Liver Panel Plus	400-0003	FDA UDI	Class I	Active
Piccolo MetLyte Plus CRP	400-0034	FDA UDI	Class II	Active
Piccolo Electrolyte Panel	400-0022	FDA UDI	Class II	Active
Piccolo Lipid Panel	400-0025	FDA UDI	Class I	Active
Piccolo AmLyte 13	400-0041	FDA UDI	Class II	Active
Piccolo MetLac 12 Panel	400-0037	FDA UDI	Class I	Active
Piccolo Basic Metabolic Panel	400-0024	FDA UDI	Class II	Active
Piccolo BioChemistry Panel Plus	400-0035	FDA UDI	Class II	Active
Piccolo(tm) Primary Health Panel Reagent Rotor	K950164	FDA 510(k)	Class I	Active
Piccolo Lactate Test System	K130113	FDA 510(k)	Class I	Active
Piccolo Magnesium Test System	K040115	FDA 510(k)	Class I	Active
Piccolo Sodium Test System	K993211	FDA 510(k)	Class II	Active
Piccolo C-Reactive Protein (crp) Test System	K091052	FDA 510(k)	Class II	Active
Piccolo Phosphorus Test System	K022312	FDA 510(k)	Class I	Active
Piccolo Total Cholesterol - Capillary Test System	K130200	FDA 510(k)	Class I	Active
Piccolo Chloride Test System	K010670	FDA 510(k)	Class II	Active
Piccolo Total Cholesterol Test System	K023642	FDA 510(k)	Class I	Active
Piccolo Metlyte 7 Reagent Disc	K992140	FDA 510(k)	Class I	Active
Piccolo Triglycerides Test System	K023639	FDA 510(k)	Class I	Active
Piccolo Hdl Test System	K023640	FDA 510(k)	Class I	Active
Epoc 2000 Point-Of-Care Analyzer And Epoc 5-Chemistry Reagent Rotor	K934592	FDA 510(k)	Class I	Active
Piccolo Magnesium Test System	K091910	FDA 510(k)	Class I	Active
Piccolo Trglycerides-Capillary Test System	K120664	FDA 510(k)	Class I	Active
Piccolo Potassium Test System	K200865	FDA 510(k)	Class II	Active
Piccolo Hdl-Capillary Test System	K120662	FDA 510(k)	Class I	Active
Gamma Glutamyl Transferase Test System	K955770	FDA 510(k)	Class I	Active
Piccolo(tm)	K942782	FDA 510(k)	Class I	Active
Piccolo Lactate Dephydrogenase Test System	K051108	FDA 510(k)	Class II	Active
Piccolo Xpress	1100-0000ER	EUDAMED	Class A	Active
Piccolo Xpress	1100-0000EI	EUDAMED	Class A	Active
Piccolo Xpress	1100-0000E	EUDAMED	Class A	Active

Related Companies

Authorised Representatives

ABAXIS Europe GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 11, 2019	Z-2361-2020	—	terminated	Incorrect reference ranges of analytes.
Nov 16, 2009	Z-1155-2010	—	terminated	Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
Apr 21, 2008	Z-2287-2008	—	terminated	The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
Apr 21, 2008	Z-2286-2008	—	terminated	The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples