Duns Number:039981550
Device Description: Beta Lactamase Test, acidometric method, 20 tests per packageAn rapid acidometric method f Beta Lactamase Test, acidometric method, 20 tests per packageAn rapid acidometric method for performing a beta-lactamase test on Haemophilus spp., S. aureus, and N. gonorrhoeae. Easy to read, clear cut color change, just add bacteria and water to tube. Not for use with anaerobes.
Catalog Number
Z51
Brand Name
N/A
Version/Model Number
Z51
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
7bb1e62b-87b6-48ba-8497-cfacc5c14185
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 2020
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |