Duns Number:119234263
Device Description: A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PC A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Catalog Number
KT03U01-2
Brand Name
Acuitas
Version/Model Number
KT03U01-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 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
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
-
Product Code
PMY
Product Code Name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Public Device Record Key
33cde9c4-a322-474a-8a83-e361808fdf5b
Public Version Date
March 28, 2022
Public Version Number
2
DI Record Publish Date
October 06, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |