Duns Number:184347305
Device Description: Positive and Negative Oral Fluid Controls
Catalog Number
OC001
Brand Name
OratectCheck Oral Fluid Controls
Version/Model Number
OC001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2018
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
K103227
Product Code
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
55a13147-9d38-4faa-b7b2-a290c36e3a14
Public Version Date
November 05, 2018
Public Version Number
4
DI Record Publish Date
July 29, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| U | Unclassified | 2 |