Skip to content

Abaxis, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000021651 FEI 2939693

Abaxis, Inc. is a medical device manufacturer based in the United States, with 42 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class I and II; EU Class A) and 5 FDA recalls as of 13 Nov 2026.

Devices
42
Registrations
EUDAMEDFDA
FDA recalls
5

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 20
  • FDA GUDID 19
  • EUDAMED 3

A device listed in two registries counts in both.

Device classes
  • FDA Class I 23
  • FDA Class II 16
  • EU Class A 3
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000021651
  • FDA FEI 2939693
  • DUNS 555503770

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
ABAXIS Europe GmbHDE

What Abaxis, Inc. makes

Abaxis, Inc. manufactures in vitro diagnostic (IVD) reagents and control products for electrolyte and metabolic testing, including glucose, creatinine, urea, sodium, potassium, bicarbonate, chloride, and calcium assays. Their portfolio also includes pre-packaged panels for hepatic function, renal function, lipid profiles, and general chemistry, designed for point-of-care and laboratory use.

These devices are classified under EU Class A, Class I, and Class II regulations, with corresponding listings in the FDA’s 510(k) and UDI databases, as well as the EU’s eudamed registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue42

Newest first, rows 1-42 of 42

Search and filter all 42 devices
Skip device list

Rows 1-42 of 42

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000021651
FDA FEI number
2939693
DUNS number
555503770
EUDAMED status
Active
EUDAMED registered name
Abaxis, Inc.
Registered address
3240, Whipple Road, 94587, Union City, United States
Phone
+1 800 822 2947
PRRC contact
Jigarkumar Modh(public in EUDAMED)

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 4 recalls initiated by ABAXIS, INC., the earliest on 2008-04-21 and the most recent on 2019-12-11. By recorded status: 4 terminated. The reasons filed fall into these groups: performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

4 initiated before 2017

  • 2019

    • 11 Dec 2019 Z-2361-2020 Class II Terminated Incorrect reference ranges of analytes. Distribution: All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees. Submission number: K934592

  • 2010

    • 19 Nov 2010 Z-1066-2011 Unclassified (pre-2012) Terminated Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer. Distribution: Worldwide distribution: USA and countries of: Kowloon and Germany. Submission number: K950164

  • 2009

    • 16 Nov 2009 Z-1155-2010 Unclassified (pre-2012) Terminated Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results. Distribution: Worldwide distribution: USA and Canada, EU and Asia Submission number: K942782

  • 2008

    • 21 Apr 2008 Z-2286-2008 Unclassified (pre-2012) Terminated The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples Distribution: Product was distributed Worldwide. Submission number: K992140
    • 21 Apr 2008 Z-2287-2008 Unclassified (pre-2012) Terminated The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples Distribution: Product was distributed Worldwide. Submission number: K992140

Frequently asked questions

How many devices does ABAXIS, INC. have in the registry?

The registry currently lists 42 devices for ABAXIS, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ABAXIS, INC.'s devices?

Among its 42 most recently registered devices, ABAXIS, INC. has devices listed in EUDAMED (3 devices), FDA 510(k) (20 devices) and FDA GUDID (19 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do ABAXIS, INC.'s devices fall under?

Among its 42 most recently registered devices, the classes recorded for ABAXIS, INC.'s devices are Class I, Class II and IVDR Class A. Each device page shows its own class and authorisation.

Are there FDA recall records for ABAXIS, INC.?

FDA recall records list 5 recalls initiated by ABAXIS, INC., the most recent initiated on 11 Dec 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from ABAXIS, INC. in the registry?

The most recently registered devices listed for ABAXIS, INC. include Piccolo Hepatic Function Panel 400-0026, Piccolo Comprehensive Metabolic Panel 400-0028, Piccolo Renal Function Panel 400-0027 and Piccolo Kidney Check 400-0033.

Generated automatically from registry data and not verified by a human reviewer.