Duns Number:039981550
Device Description: SPS Disks, 1mg, 1 x 50 disks, for identification of Gardnerella vaginalis and P. anaerobiu SPS Disks, 1mg, 1 x 50 disks, for identification of Gardnerella vaginalis and P. anaerobiusHardyDisk™ SPS Identification Disks evaluate the ability of an organism to grow in the presence of Sodium Polyanethol Sulfonate. HardyDisk™ SPS Identification Disks can be used to presumptively identify microorganisms including but not limited to Peptostreptococcus anaerobius, Gardnerella vaginalis, and Haemophilus ducreyi.
Catalog Number
Z7381
Brand Name
HardyDisk™
Version/Model Number
Z7381
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
dfd70333-6c0b-4add-afdc-ae8107b15385
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 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 |