FDA Registration
Active
🇺🇸 United States
ABAXIS, INC.
Reg #: 2939693
·
FEI: 2939693
·
Expires 2026
Products
28
Proprietary Names
20
Establishment Types
1
Classifications
28
Registration Details
- Registration Name
- ABAXIS, INC.
- Registration Number
- 2939693
- FEI Number
- 2939693
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3240 WHIPPLE RD.
- City
- UNION CITY
- State
- CA
- ZIP
- 94587
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010670
Owner / Operator
- Firm Name
- ZOETIS, INC.
- Operator Number
- 9000378
- Address
- 3240 WHIPPLE RD., --
- City
- Union City
- State
- CA
- Postal Code
- 94587
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mercuric Thiocyanate, Colorimetry, Chloride | CHJ | Class 2 | Clinical Chemistry | No | 2009-03-27 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2006-01-10 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2010-03-26 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2006-01-10 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2003-06-30 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2003-06-30 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | Class 1 | Clinical Chemistry | No | 2006-01-20 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2001-05-21 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2007-05-30 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Urease, Photometric, Urea Nitrogen | CDN | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Phenylphosphate, Alkaline Phosphatase Or Isoenzymes | CKF | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Saccharogenic, Amylase | CIJ | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2007-05-30 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2015-04-30 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2006-01-10 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2013-05-02 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2012-03-29 |
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | Class 1 | Clinical Chemistry | No | 2012-03-29 |
| Tetraphenyl Borate, Colorimetry, Potassium | CEJ | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2007-05-30 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2009-03-27 |
Proprietary Names
PICCOLO CHLORIDE TEST SYSTEM
PICCOLO PHOSPHORUS TEST SYSTEM
Piccolo CRP Test System
PICCOLO MAGNESIUM TEST SYSTEM
PICCOLO TRIGLYCERIDE TEST SYSTEM
PICCOLO HIGH DENSITY LIPOPROTEIN (H
Aspartate Aminotransferase (AST)
Uric Acid
Piccolo Xpress
PICCOLO GGT TEST SYSTEM
PICCOLO PRIMARY HEALTH PANEL
Piccolo Uric Acid Test System
PICCOLO LACTATE DEHY
Piccolo Lactate Test System
Total Carbon Dioxide
Creatine Kinase
Enzymatic Potassium
PICCOLO TOTAL CHOL
PICCOLO 9-CHEM REAGENT ROTOR
PICCOLO SODIUM TEST SYSTEM
Establishment Types
Manufacture Medical Device