Duns Number:317134468
Device Description: Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassay Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays
Catalog Number
SLV-4158
Brand Name
SALI-TUBES 100
Version/Model Number
SLV-4158
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
K040923
Product Code
JLS
Product Code Name
RADIOIMMUNOASSAY, PROGESTERONE
Public Device Record Key
1decd5d5-2d8f-494a-88b5-d4d2b73c3240
Public Version Date
June 15, 2021
Public Version Number
1
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 |