AccessGUDID - DEVICE: Podoplanin/D2-40 control slides (B502BSB60700)

GUDID

Device Identifier (DI) Information

Brand Name: Podoplanin/D2-40 control slides
Version or Model: Control Slides, 5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 6070
Company Name: BIO SB, INC.

Primary DI Number: B502BSB60700
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: Podoplanin/D2-40, Control

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?
57171	D2-40 antigen 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 D2-40 mesothelial/endothelial marker, also known as M2A antigen, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJG	Quality Control Slides

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: 0934b9b1-ba92-4466-9f3f-c922577ce6f3
Public Version Date: June 23, 2020
Public Version Number: 1
DI Record Publish Date: June 15, 2020