Duns Number:117458512
Device Description: MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of S MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Catalog Number
-
Brand Name
MRSA/SA ELITe MGB
Version/Model Number
M800346
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
K112937
Product Code
NQX
Product Code Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Public Device Record Key
b3cdd036-7c3d-47b3-899f-c2adf32ff9d5
Public Version Date
October 15, 2020
Public Version Number
4
DI Record Publish Date
October 13, 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 | 106 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |