BOSTON CELL STANDARDS INC

FDA Registration(s)#

Registration, FEI, Name table
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 table
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 table
Product code	Registration listing records	Latest decision
NJW	1	2022-08-15

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.
Boston Cell Standards Inc
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.
Boston Cell Standards Inc
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.
Boston Cell Standards Inc
2023-11-14