Duns Number:965476641
Device Description: The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in v The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
Catalog Number
-
Brand Name
ARIES® GBS Assay
Version/Model Number
50-10021
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
K162772
Product Code
NJR
Product Code Name
Nucleic acid amplification assay system, group b streptococcus, direct specimen test
Public Device Record Key
1e2e2829-8216-422e-96e7-b5c09295539d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 10, 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 |