Duns Number:276816717
Device Description: API® Staph is a standardized system for the identification of the genera Staphylococcus, M API® Staph is a standardized system for the identification of the genera Staphylococcus, Micrococcus and Kocuria
Catalog Number
-
Brand Name
API® Staph
Version/Model Number
20500
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
-
Product Code
JWX
Product Code Name
KIT, SCREENING, STAPHYLOCOCCUS AUREUS
Public Device Record Key
1591efb7-2670-46db-9293-f0cddfe0c46f
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 10, 2020
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |