Duns Number:051624070
Device Description: Liquichek Elevated CRP Control MiniPak (A human serum C-Reactive Protein control.)
Catalog Number
255X
Brand Name
Liquichek
Version/Model Number
255X
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042837
Product Code
JJX
Product Code Name
Single (specified) analyte controls (assayed and unassayed)
Public Device Record Key
c9d65b42-833a-474e-93c1-38b093419943
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
January 16, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |