Duns Number:965476641
Device Description: The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualit The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis.
Catalog Number
-
Brand Name
ARIES® Group A Strep Assay
Version/Model Number
50-10041
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
K172402
Product Code
OOI
Product Code Name
real time Nucleic acid amplification system
Public Device Record Key
dc5c6754-e593-4f7a-812b-9d604ef7b7e6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 07, 2017
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 | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |