Duns Number:061446282
Device Description: Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Cont Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum) are run controls to be used in Capture-R solid phase assays. The Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells. The Capture-R Negative Control Serum does not contain antibodies to red blood cells. This product configuration has one (1) vial of each control, at a volume of 11.5 mL each.
Catalog Number
0066236
Brand Name
Capture-R Control set
Version/Model Number
0066236
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
5e8946ed-91c5-4f6c-b39d-17d96157c8b9
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
April 18, 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 |