Duns Number:061446282
Device Description: The Capture-CMV Control set is composed of both negative and weak positive control materia The Capture-CMV Control set is composed of both negative and weak positive control material to control the Capture-CMV test.
Catalog Number
0066239
Brand Name
Capture-CMV Control set
Version/Model Number
0066239
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)
Yes
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
K910003
Product Code
LJO
Product Code Name
Antigen, Iha, Cytomegalovirus
Public Device Record Key
835bd600-b11c-4fe0-9e04-8e66fc9e36ff
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 14, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |