Duns Number:051624070
Device Description: Liquichek ANA Control, Homogeneous Pattern Positive (A pre-diluted human serum autoimmune Liquichek ANA Control, Homogeneous Pattern Positive (A pre-diluted human serum autoimmune control.)
Catalog Number
107
Brand Name
Liquichek
Version/Model Number
107
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
K024221
Product Code
DHN
Product Code Name
ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
Public Device Record Key
2a531831-b78e-4d62-84ca-8e1b74ece3ed
Public Version Date
July 29, 2021
Public Version Number
6
DI Record Publish Date
September 12, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |