Duns Number:317134468
Device Description: The DRG:HYBRiD-XL® is a fully automated random access analyzer.The innovative technology o The DRG:HYBRiD-XL® is a fully automated random access analyzer.The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples.The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays.
Catalog Number
HYB-5252
Brand Name
DRG:HYBRiD.XL®
Version/Model Number
HYB-5252
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJQ
Product Code Name
COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE
Public Device Record Key
08e9313b-1d8b-4960-97fd-d73226226bbd
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
June 07, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |