Duns Number:086785110
Device Description: Mycobacteria Detection bottle for recovery and detection of mycobacteria from sterile body Mycobacteria Detection bottle for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
Catalog Number
-
Brand Name
BACT/ALERT® MP
Version/Model Number
BACT/ALERT MP
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
K190405,K190405,K190405
Product Code
MDB
Product Code Name
System, blood culturing
Public Device Record Key
9d102ca5-894f-4310-a514-2af48f92deeb
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 2020
Package DI Number
03573026611798
Quantity per Package
50
Contains DI Package
03573026596163
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |