Duns Number:039981550
Device Description: XV Factor, HardyDisks™, Hemin and NAD disk to aid in the identification of Haemophilus spp XV Factor, HardyDisks™, Hemin and NAD disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 eachContains NAD and Hemin (X and V Factors) for the speciation of Haemophilus.
Catalog Number
Z7051
Brand Name
HardyDisk™
Version/Model Number
Z7051
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
ac221417-dfed-44f9-8636-ad33776ef0f5
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 |