Duns Number:092815364
Device Description: Alethia™ is an automated isothermal amplification and detection system for use with Meridi Alethia™ is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc.’s Alethia Loop-Mediated Amplification assays.
Catalog Number
610189
Brand Name
Alethia™
Version/Model Number
610189
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
K100818
Product Code
OOI
Product Code Name
Real Time Nucleic Acid Amplification System
Public Device Record Key
e1c3e2cb-340d-4a97-bce8-ce3e2edcb1ab
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 08, 2019
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 |