AccessGUDID - DEVICE: PolyDetector AP Blocker (B502BSB00590)

GUDID

Device Identifier (DI) Information

Brand Name: PolyDetector AP Blocker
Version or Model: 1000 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0059
Company Name: BIO SB, INC.

Primary DI Number: B502BSB00590
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: PolyDetector AP Blocker is used to block the endogenous alkaline phosphatase enzymes that naturally occur in cells and tissue sections without affecting antigens or nucleic acids.

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:	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?
57767	Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: 4f5622b4-8a1e-4b2b-b290-17c71604f697
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020