AccessGUDID - DEVICE: HER2 neu PolyDetector DAB HRP Brown Detection System (B502BSB02450)

GUDID

Device Identifier (DI) Information

Brand Name: HER2 neu PolyDetector DAB HRP Brown Detection System
Version or Model: 70 tests
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0245
Company Name: BIO SB, INC.

Primary DI Number: B502BSB02450
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: HER-2 neu PolyDetector DAB HRP Brown Detection System is a non-biotin, 1-step polymeric detection system that allows for the Immunohistochemical detection of HER-2 neu overexpression.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
57771	Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may include diaminobenzidine (DAB), aminoethylcarbazole (AEC), nitro blue tetrazolium/bromochloroindolyl phosphate (NBT/BCIP) and/or fast red using an enzyme immunohistochemistry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 88bc5611-e2d8-444e-b2c8-4a8c7937ca20
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020