Duns Number:244713368
Device Description: Prepared from human source plasma and recommended as a negative control in assays for lupu Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
Catalog Number
CCLN-10
Brand Name
CRYOcheck Lupus Negative Control
Version/Model Number
CCLN-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
-
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
280c5d5f-0745-40cc-b194-1c74b1f61ba2
Public Version Date
March 16, 2020
Public Version Number
1
DI Record Publish Date
March 06, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |