AccessGUDID - DEVICE: PolyDetector Alk Scarlet (B502BSB01410)

GUDID

Device Identifier (DI) Information

Brand Name: PolyDetector Alk Scarlet
Version or Model: 200 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0141
Company Name: BIO SB, INC.

Primary DI Number: B502BSB01410
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: PolyDetector ALK Scarlet Substrate-Chromogen used in Alkaline Phosphatase Detection Systems for the demonstration of cell antigens or nucleic acids in paraffin-embedded tissues, cryostat sections, cytosmears, and cell preparations.

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?
58239	Chromogenic/colorimetric substrate reagent IVD	A substance or reactant that produces colour in response to a biochemical reaction and intended to be used in combination with other IVDs to test a clinical specimen, typically using an enzyme immunoassay or immunoblot method. Substrate examples include NBT, BCIP, TMB, 4CN, DAB.	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: 389ce22e-a000-4c09-ac64-72d9e32f7905
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: September 30, 2020