DEVICE: Piccolo MetLyte Plus CRP (EABA40000341)
Device Identifier (DI) Information
Piccolo MetLyte Plus CRP
400-0034
In Commercial Distribution
400-0034
ABAXIS, INC.
400-0034
In Commercial Distribution
400-0034
ABAXIS, INC.
The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) 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.
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? |
|---|---|---|---|---|
| 53707 | C-reactive protein (CRP) 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 C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].
|
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 |
| 53006 | Total creatine kinase (CK) 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 creatine kinase (CK) 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 |
|---|---|
| DCN | System, Test, C-Reactive Protein |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride |
| JGS | Electrode, Ion Specific, Sodium |
| KHS | Enzymatic, Carbon-Dioxide |
| CEM | Electrode, Ion Specific, Potassium |
| JLB | Atp And Creatine Kinase (Enzymatic), Creatine |
| 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 |
| K091052 | 000 |
| K934592 | 000 |
| K942782 | 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
3015c06d-d980-4781-a503-a1f2450ea422
December 20, 2022
6
September 23, 2016
December 20, 2022
6
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:
EABA40000340
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-822-2947
Piccolo@abaxis.com +496155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com
Piccolo@abaxis.com +496155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com