Duns Number:045361136
Device Description: A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testi A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System.
Catalog Number
503000
Brand Name
STAT-Site Hgb Controls
Version/Model Number
503000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2019
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
-
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
a7c05f2b-371d-4f69-9afe-8d7e296d82d5
Public Version Date
September 02, 2019
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |