Duns Number:070556204
Device Description: Curaplex Control Solution 2/BT
Catalog Number
2762-32702
Brand Name
Curaplex
Version/Model Number
2762-32702
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJX
Product Code Name
Single (specified) analyte controls (assayed and unassayed)
Public Device Record Key
c0a629dc-e019-4a34-97bd-2f24b10871d2
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
December 15, 2018
Package DI Number
00812277030082
Quantity per Package
20
Contains DI Package
00812277030075
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |