Duns Number:092815364
Device Description: Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus a Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens.
Catalog Number
696004
Brand Name
PREMIER Rotaclone
Version/Model Number
696004
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
K852969
Product Code
LIQ
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Public Device Record Key
6353a76d-1a7d-4e9d-8faf-69dc2a0e62de
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |