Duns Number:614218634
Device Description: The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
Catalog Number
-
Brand Name
TRI-COMBO PARASITE SCREEN
Version/Model Number
T5032
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
K171078
Product Code
KHW
Product Code Name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Public Device Record Key
53648e1b-3105-4d20-b673-c7096d0ca3b7
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
May 31, 2019
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 |