Duns Number:080589004
Device Description: Immunalysis Corporation HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugat Immunalysis Corporation HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL)
Catalog Number
-
Brand Name
Immunalysis Corporation
Version/Model Number
GPR-E-180-1000
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
b684bb92-6235-484b-af28-6d0be36c6012
Public Version Date
March 11, 2020
Public Version Number
3
DI Record Publish Date
September 05, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |