Duns Number:151765328
Device Description: "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
Catalog Number
-
Brand Name
Diamedix
Version/Model Number
300-371A
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K980759
Product Code
LLL
Product Code Name
Extractable Antinuclear Antibody, Antigen And Control
Public Device Record Key
44fe63be-5580-4299-8687-1bd4b2c08740
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
September 20, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |