Duns Number:122561087
Device Description: BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay Reagent Pack, 384 tests
Catalog Number
443433
Brand Name
BD ProbeTec™ Trichomonas vaginalis
Version/Model Number
443433
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
K130268
Product Code
OUY
Product Code Name
Trichomonas vaginalis nucleic acid amplification test system
Public Device Record Key
733af3e8-cf6c-4a73-b0ec-8a4f53df8ec7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 07, 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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |