AccessGUDID - DEVICE: HER2/ER/PR IHControls® (00850045519001)

GUDID

Device Identifier (DI) Information

Brand Name: HER2/ER/PR IHControls®
Version or Model: Level H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRLS11
Company Name: Boston Cell Standards Inc

Primary DI Number: 00850045519001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126775860 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57049	Human epidermal growth factor receptor 2 (HER2) protein IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJW	Control Material, Her-2/Neu, Immunohistochemistry

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220163	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9f1c3c4-7aa8-425f-9962-e4e3a8ded10e
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: November 14, 2023