Duns Number:081586435
Device Description: NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be us NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays.
Catalog Number
NATCTNGNEG-6MC
Brand Name
NATtrol™
Version/Model Number
NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control
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)
-
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
9358ccbb-a8de-4412-bafb-00b025c59759
Public Version Date
June 21, 2021
Public Version Number
1
DI Record Publish Date
June 11, 2021
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 |