Duns Number:102855447
Device Description: Estrogen receptor is a rabbit monoclonal antibody for immunohistochemistry derived from ce Estrogen receptor is a rabbit monoclonal antibody for immunohistochemistry derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
Catalog Number
BSB 5493
Brand Name
Tinto Estrogen Receptor RMab
Version/Model Number
Predilute, 15 ml
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
3ddae51c-9ae3-43f8-8d24-eed83f05d86f
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 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 | 3887 |