Duns Number:894671143
Device Description: FLEX Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4 Ready-to-Use (Dako Omnis FLEX Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4 Ready-to-Use (Dako Omnis)
Catalog Number
-
Brand Name
FLEX Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 RTU (Dako Omnis)
Version/Model Number
GA637
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NJT
Product Code Name
IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
Public Device Record Key
b87c805e-aa20-48fe-8917-0f54e1a6470a
Public Version Date
December 07, 2020
Public Version Number
2
DI Record Publish Date
September 17, 2020
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 | 490 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |
| 3 | A medical device with high risk that requires premarket approval | 5 |