HER2/ER/PR IHControls®

Primary DI
00850045519001
Brand
HER2/ER/PR IHControls®
Company
Boston Cell Standards Inc
Model
Level H
Catalog number
BRLS11
Device description
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.
Published
2023-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NJWControl Material, Her-2/Neu, Immunohistochemistry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJWControl Material, Her-2/Neu, ImmunohistochemistryHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220163000Her-2, ER, PR IHControlsBoston Cell Standards, Inc.2022-08-15NJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045519001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045519001008500455190018500455190010850045519001

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126775860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045519018HER2/ER/PR IHControls®Level MBRL2U042023-11-14
00850045519025HER2/ER/PR IHControls®Level LBRL2W082023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045519018HER2/ER/PR IHControls®Boston Cell Standards IncNJW2023-11-14
00850045519025HER2/ER/PR IHControls®Boston Cell Standards IncNJW2023-11-14