Duns Number:039981550
Device Description: Modified Field's Stain Kit, for protozoa such as Acanthamoeba, two 15ml bottles per kitSta Modified Field's Stain Kit, for protozoa such as Acanthamoeba, two 15ml bottles per kitStaining solution for microscopic examination of Protozoa such as Acanthamoeba and Trichomonas spp.Contains:Reagent A (1) 00819398027045Reagent B (1) 00819398027052
Catalog Number
Z15
Brand Name
N/A
Version/Model Number
Z15
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
5970ac49-bd87-4d35-8e55-39e3a47fd485
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 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 |