Duns Number:045623154
Device Description: Pointe Calcium Reagent packaged for use on the Mindray BA800. 5 x 66ml R1, 5 x 30ml R2. Pointe Calcium Reagent packaged for use on the Mindray BA800. 5 x 66ml R1, 5 x 30ml R2. For the quantitative determination of calcium in serum on Mindray BA-800M analyzers. For in vitro diagnostic use only. Rx Only
Catalog Number
16-HC902-480
Brand Name
Pointe Calcium Reagent
Version/Model Number
16-HC902-480
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
-
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
K822469
Product Code
CIC
Product Code Name
Cresolphthalein Complexone, Calcium
Public Device Record Key
fbf49a8a-2107-4268-bbe7-e0373bd9a8bd
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 2021
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |