Identity
- Trade Name
- Piccolo BioChemistry Panel Plus FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
- Device Name
- The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. FDA UDI
- Model / Reference
- 400-0035 FDA UDI
- Description
- The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. FDA UDI
Identifiers
- Catalog Number
- 400-0035 FDA UDI
- Primary DI / UDI-DI
- EABA40000351 FDA UDI
- FDA Product Code
- CIT FDA UDICGA FDA UDICEK FDA UDIKNK FDA UDICJW FDA UDICGX FDA UDICDN FDA UDICKA FDA UDICKF FDA UDICIJ FDA UDICJY FDA UDIJQB FDA UDIDCN FDA UDI
- GMDN Term
- Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1100 FDA UDI862.1345 FDA UDI862.1635 FDA UDI862.1775 FDA UDI862.1035 FDA UDI862.1225 FDA UDI862.1770 FDA UDI862.1030 FDA UDI862.1050 FDA UDI862.1070 FDA UDI862.1145 FDA UDI862.1360 FDA UDI866.5270 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uric acid IVD, reagentAlanine aminotransferase (ALT) IVD, reagentTotal aspartate aminotransferase (AST) IVD, reagentGamma-glutamyltransferase (GGT) IVD, reagent
Piccolo BioChemistry Panel Plus by Abaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abaxis, Inc.
Sources (1)
- FDA UDI f2d0d500-ff43-4b3e-9362-6e7eab72ae28 36 fields · synced May 30, 2026