Duns Number:956711444
Device Description: Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L
Catalog Number
900-0485
Brand Name
GeneXpert Dx System
Version/Model Number
GXII-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060540,K173263
Product Code
OOI
Product Code Name
Real Time Nucleic Acid Amplification System
Public Device Record Key
7274db95-6e22-4975-8429-4866ff9cb9d2
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
September 12, 2016
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 | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 78 |