Duns Number:039981550
Device Description: AFB Nitrate Reagent A, (sulfanilimide, 0.2%), for AFB Nitrate Test for mycobacteria identi AFB Nitrate Reagent A, (sulfanilimide, 0.2%), for AFB Nitrate Test for mycobacteria identification, 15ml Spot DropAFB nitrate developer reagent is to be used with Nitrate Substrate Broth, Hardy Diagnostics (Cat. no. R97) and AFB Nitrate Reagent B (Cat. no Z125). Reagent A contains sulfanilimide.
Catalog Number
Z124
Brand Name
N/A
Version/Model Number
Z124
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
891b0630-1607-49bc-9aff-1a416475b407
Public Version Date
June 18, 2020
Public Version Number
1
DI Record Publish Date
June 10, 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 |