Duns Number:122561087
Device Description: BD ProbeTec™ Herpes Simplex Viruses (HSV1&2) Qx Amplified DNA Assays Reagent Pack
Catalog Number
441749
Brand Name
BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack
Version/Model Number
441749
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
K103798
Product Code
OQO
Product Code Name
Herpes simplex virus nucleic acid amplification assay
Public Device Record Key
5164c1b6-fc36-4735-99fe-873f6409e44d
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 |