Duns Number:878263359
Device Description: Alinity m STI AMP Kit
Catalog Number
09N17-095
Brand Name
Alinity m
Version/Model Number
09N17-095
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)
Yes
FDA Premarket Submission
K202977
Product Code
QEP
Product Code Name
Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
Public Device Record Key
67c7d244-c2d3-4313-ae78-eca2e76ecb95
Public Version Date
May 27, 2022
Public Version Number
1
DI Record Publish Date
May 19, 2022
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 | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |