Her-2, ER, PR IHControls
Boston Cell Standards, Inc.
BOSTON CELL STANDARDS INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023212278 | 3023212278 | BOSTON CELL STANDARDS INC | 1 | N | 2026-01-01 | 800 Washington Street Ziskind 417 Boston MA US 02111 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 309350 | 1455703401 | K220163 | Her-2, ER, PR IHControls | NJW | 2022-08-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NJW | 1 | 2022-08-15 |
PMN#
GUDID#
HER2/ER/PR IHControls® - HER2/ER/PR IHControls® - Level H are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
2023-11-14
HER2/ER/PR IHControls® - HER2/ER/PR IHControls® - Level M are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
2023-11-14
HER2/ER/PR IHControls® - HER2/ER/PR IHControls® - Level L are immunostainingpositive controls for diagnostic immunohistochemistry laboratories. The sameimmunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
2023-11-14