Duns Number:039981550
Device Description: Nitrate Reagent C, Zinc Dust, 5gmFor the completion of the nitrate reduction test. Confirm Nitrate Reagent C, Zinc Dust, 5gmFor the completion of the nitrate reduction test. Confirms negatives after adding Nitrate A, product number Z124 or Z71; and Nitrate B, product number Z125 or Z72 reagents. True negatives will turn red after the zinc dust is added.
Catalog Number
Z73
Brand Name
N/A
Version/Model Number
Z73
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
a36717d0-0445-4d96-b16d-46b5222d7121
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 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 |