Duns Number:503499167
Catalog Number
RK041A
Brand Name
ZYMUTEST HIA MonoStrip IgG
Version/Model Number
RK041A
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
K071255
Product Code
LCO
Product Code Name
Platelet Factor 4 Radioimmunoassay
Public Device Record Key
dac2ea18-c5b8-4921-ace4-d1b3c6c546dd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 25, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |