Duns Number:227530649
Device Description: The calcium method used on the Dimension clinical chemistry system is an in vitro diagnost The calcium method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of calcium concentration in serum.
Catalog Number
CA2807
Brand Name
Ca
Version/Model Number
CA2807
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000375
Product Code
CIC
Product Code Name
Cresolphthalein Complexone, Calcium
Public Device Record Key
3783cddc-ebfd-4984-814c-ca1e40b3c213
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |