Duns Number:114152184
Catalog Number
-
Brand Name
OraQuick HCV Rapid Antibody Test Kit Controls
Version/Model Number
1001-0182
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027
Product Code
MZO
Product Code Name
Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus
Public Device Record Key
b3c9ccd1-3e18-4c1f-be5c-239d90483314
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 05, 2014
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |