Duns Number:555503770
Device Description: The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or 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.
Catalog Number
400-0031
Brand Name
Piccolo Basic Metabolic Panel Plus
Version/Model Number
400-0031
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993211,K992140,K950164,K942782,K934592,K051108,K040115,K010670,K993211,K992140,K950164,K942782,K934592,K051108,K040115,K010670
Product Code
CDN
Product Code Name
Urease, Photometric, Urea Nitrogen
Public Device Record Key
bd6e9fd5-699e-4231-8ac8-f1e8c359bffb
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |