Duns Number:315028860
Device Description: Anti-HCV II 200-Test Kit
Catalog Number
06427405160
Brand Name
Elecsys Anti-HCV II
Version/Model Number
06427405160
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
P140021,P140021
Product Code
MZO
Product Code Name
Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus
Public Device Record Key
3ea84d2c-d26d-4a8b-a225-c6928a2e0dc3
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
October 03, 2017
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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 760 |
| 3 | A medical device with high risk that requires premarket approval | 63 |
| U | Unclassified | 4 |