Duns Number:092815364
Device Description: The Para-Pak SAF is a convenient system for the routine collection, transportation, preser The Para-Pak SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Catalog Number
910212
Brand Name
Para-Pak SAF (Genova Diagnostics)
Version/Model Number
9002-08
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IGG
Product Code Name
Formaldehyde (Formalin, Formol)
Public Device Record Key
fda86a86-5e7e-41dc-a45e-f0b0f2d1dff8
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 27, 2021
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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |