Duns Number:081586435
Device Description: NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) DI number 01220000260290, and NATtrol Vaginal Negative Control (NATVNEG-6C) DI number 01220000260306, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.
Catalog Number
NATV-BU1
Brand Name
NATtrol™
Version/Model Number
NATtrol™ Vaginal Bundle
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHQ
Product Code Name
Multi-Analyte Controls Unassayed
Public Device Record Key
496baece-2ead-4479-849b-14b4c7c92395
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |