Duns Number:555503770
Device Description: The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyze The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
Catalog Number
400-0037
Brand Name
Piccolo MetLac 12 Panel
Version/Model Number
400-0037
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,K130113,K040115,K022312,K010670,K010670,K993211,K992140,K950164,K942782,K934592,K130113,K040115,K022312
Product Code
CDN
Product Code Name
Urease, Photometric, Urea Nitrogen
Public Device Record Key
6c2ced0e-e535-4db2-8ab2-0f9dd0bd3839
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 |