Duns Number:005088112
Device Description: Stratus® CS STAT Fluorometric Analyzer Rotor is an in vitro diagnostics device which is in Stratus® CS STAT Fluorometric Analyzer Rotor is an in vitro diagnostics device which is intended to be used on the Stratus® CS analyzer.
Catalog Number
CROTOR
Brand Name
Stratus® CS STAT Fluorometric Analyzer Rotors
Version/Model Number
10445088
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K984067,K984067
Product Code
JHX
Product Code Name
FLUOROMETRIC METHOD, CPK OR ISOENZYMES
Public Device Record Key
9740cf8e-8dc1-4ee5-bb1f-f0e4c22fc1ca
Public Version Date
November 19, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |