Duns Number:614218634
Device Description: The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detecti The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.
Catalog Number
-
Brand Name
GIARDIA/CRYPTOSPORIDIUM CHEK
Version/Model Number
30401
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051929
Product Code
MHJ
Product Code Name
Cryptosporidium Spp.
Public Device Record Key
a99b9f71-9b0e-44de-89e1-3fd2ccd5702e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 23, 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 | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |