Duns Number:614218634
Device Description: The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamb The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children.
Catalog Number
-
Brand Name
GIARDIA II
Version/Model Number
PT5012
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
K033274
Product Code
MHI
Product Code Name
Giardia Spp.
Public Device Record Key
e468ff67-a0c6-47c1-a18e-475b943c1a55
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 |