AccessGUDID - DEVICE: PIN MultiDetector HRP\AP Detection kit (B502BSB035270)

GUDID

Device Identifier (DI) Information

Brand Name: PIN MultiDetector HRP\AP Detection kit
Version or Model: Ready-to-use, 70 tests each
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0352
Company Name: BIO SB, INC.

Primary DI Number: B502BSB035270
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: Read-to-Use, Prostate Intraepithelial Neoplasia (PIN) kit is a multiplex triple color IHC Kit designed to detect prostate cancer in situ in the prostate glands.

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: 2fe064d8-c0c0-46c6-9720-dd9a70a47d6f
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020