Duns Number:614218634
Device Description: The QuickVue TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay The QuickVue TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The QuickVue TLI Campylobacter Test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.
Catalog Number
-
Brand Name
QuickVue TLI Campylobacter Test
Version/Model Number
20344
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
K173217
Product Code
LQP
Product Code Name
Campylobacter Spp.
Public Device Record Key
a2acc3a6-bcd4-482e-86bf-a5c60ae51a42
Public Version Date
June 07, 2019
Public Version Number
1
DI Record Publish Date
May 30, 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 |