Duns Number:008496861
Device Description: The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts an The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests.
Catalog Number
MCC-C/G-DFA 75
Brand Name
Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay
Version/Model Number
MCC-C/G-DFA 75
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
K024113
Product Code
MHI
Product Code Name
Giardia Spp.
Public Device Record Key
06f6a366-1c84-4c1a-a5f1-6c06dc00be0b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |