Duns Number:315786293
Device Description: Architect Anti-HCV Controls
Catalog Number
01L7910
Brand Name
ARCHITECT
Version/Model Number
1L79-10
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
P050042,P050042,P050042,P050042,P050042,P050042,P050042
Product Code
MZO
Product Code Name
ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
Public Device Record Key
5a2704ff-738c-49d8-909e-559e783d1aa4
Public Version Date
June 22, 2020
Public Version Number
4
DI Record Publish Date
November 18, 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 | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 185 |
| 3 | A medical device with high risk that requires premarket approval | 13 |