Duns Number:184020902
Device Description: NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run cont NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens.NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.
Catalog Number
MDZ001
Brand Name
NATtrol™
Version/Model Number
NATtrol™ RP Multimarker Controls
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
abda68f4-efb1-46f1-9895-ddaf00e37349
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
October 14, 2020
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 |