DEVICE: Piccolo Basic Metabolic Panel Plus (EABA40000311)
Device Identifier (DI) Information
Piccolo Basic Metabolic Panel Plus
400-0031
In Commercial Distribution
400-0031
ABAXIS, INC.
400-0031
In Commercial Distribution
400-0031
ABAXIS, INC.
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 53074 | Total lactate dehydrogenase (LDH) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total lactate dehydrogenase (LDH) in a clinical specimen.
|
Active | false |
| 52883 | Magnesium (Mg2+) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of magnesium (Mg2+) in a clinical specimen.
|
Active | false |
| 52879 | Chloride (Cl-) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of chloride (Cl-) in a clinical specimen.
|
Active | false |
| 52898 | Sodium (Na+) IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen.
|
Active | false |
| 52873 | Bicarbonate (HCO3-) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) in a clinical specimen.
|
Obsolete | false |
| 52895 | Potassium (K+) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of potassium (K+) in a clinical specimen.
|
Active | false |
| 52875 | Calcium (Ca2+) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.
|
Active | false |
| 53590 | Urea IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.
|
Active | false |
| 53252 | Creatinine IVD, reagent |
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.
|
Active | false |
| 53307 | Glucose IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
| JGJ | Photometric Method, Magnesium |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride |
| JGS | Electrode, Ion Specific, Sodium |
| KHS | Enzymatic, Carbon-Dioxide |
| CEM | Electrode, Ion Specific, Potassium |
| CJY | Azo Dye, Calcium |
| CDN | Urease, Photometric, Urea Nitrogen |
| CGX | Alkaline Picrate, Colorimetry, Creatinine |
| CGA | Glucose Oxidase, Glucose |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K010670 | 000 |
| K040115 | 000 |
| K051108 | 000 |
| K934592 | 000 |
| K942782 | 000 |
| K950164 | 000 |
| K992140 | 000 |
| K993211 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit |
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
bd6e9fd5-699e-4231-8ac8-f1e8c359bffb
December 20, 2022
5
September 23, 2016
December 20, 2022
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
EABA40000310
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-822-2947
Piccolo@abaxis.com +49 6155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com
Piccolo@abaxis.com +49 6155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com