Abaxis Inc
Union City, CA, US
ABAXIS, INC. appears in FDA device records in Union City, CA. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Abaxis Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abaxis, Incorporatedrecall
510(k) clearance history
FDA records hold 20 510(k) clearances for Abaxis Inc between 1994 and 2021. The busiest year on record is 2003, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200865 | Piccolo Potassium Test System | MZV | Substantially Equivalent | |
| K130113 | PICCOLO LACTATE TEST SYSTEM | KHP | Substantially Equivalent | |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | CHH | Substantially Equivalent | |
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | JGY | Substantially Equivalent | |
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | JHM | Substantially Equivalent | |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | DCN | Substantially Equivalent | |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | JGJ | Substantially Equivalent | |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | CFJ | Substantially Equivalent | |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | JGJ | Substantially Equivalent | |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | CHH | Substantially Equivalent | |
| K023640 | PICCOLO HDL TEST SYSTEM | LBS | Substantially Equivalent | |
| K023639 | PICCOLO TRIGLYCERIDES TEST SYSTEM | JGY | Substantially Equivalent | |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | CEO | Substantially Equivalent | |
| K010670 | PICCOLO CHLORIDE TEST SYSTEM | CHJ | Substantially Equivalent | |
| K993211 | PICCOLO SODIUM TEST SYSTEM | JGS | Substantially Equivalent | |
| K992140 | PICCOLO METLYTE 7 REAGENT DISC | JLB | Substantially Equivalent | |
| K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | JQB | Substantially Equivalent | |
| K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR | CHH | Substantially Equivalent | |
| K942782 | PICCOLO(TM) | JJG | Substantially Equivalent | |
| K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | JJG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2939693 | 2939693 | ABAXIS, INC. | 3240 WHIPPLE RD., UNION CITY, CA 94587 US | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use
- JLBAtp And Creatine Kinase (Enzymatic), Creatine
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CJWBromcresol Purple Dye-Binding, Albumin
- JHMColorimetric Method, Lipoproteins
- JGYColorimetric Method, Triglycerides
- CIGDiazo Colorimetry, Bilirubin
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- CGAGlucose Oxidase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CIJSaccharogenic, Amylase
- DCNSystem, Test, C-Reactive Protein
- MZVTest, System, Potassium, Enzymatic Method
- CEJTetraphenyl Borate, Colorimetry, Potassium
- CDNUrease, Photometric, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2361-2020 | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) | Incorrect reference ranges of analytes. | Class II | Terminated | |
| Z-1066-2011 | Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; Product is manufactured and distributed by Abaxis, Incorporated, Union City, CA The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented selfcontained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment. | 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. | Terminated | ||
| Z-1155-2010 | Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum. | Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results. | Terminated | ||
| Z-2287-2008 | Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination. | The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples | Terminated | ||
| Z-2286-2008 | Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-contained reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination. | The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Abaxis Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain